Trial Outcomes & Findings for A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (NCT NCT04614948)

NCT ID: NCT04614948

Last Updated: 2025-02-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 31835 participants
• Primary outcome timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)
• Results posted on: 2025-02-04

Participant Flow

Total of 31835 participants were randomized, out of which 130 participants were randomized but not vaccinated. Hence, 31705 participants received vaccination in both double blind (DB) and open label (OL) phase. After completion of DB phases more participants were enrolled therefore, the started count of DB+OL phase is exceeding the started count for DB phase.

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

Participant milestones

Measure	Combined Double-blind and Open-label Phase: All Participants Each participant was initially randomized to receive 1 dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, participants could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all participants were unblinded and entered OL phase, and those participants that received placebo could receive a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine for those participants that received a single dose of Ad26.COV2.S vaccine in the study.	Double Blind Phase: Ad26.COV2.S Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.
DB Phase (Day 1 up to 7.2 Months) STARTED	0	15708	15592
DB Phase (Day 1 up to 7.2 Months) FAS Post-Dose 1 Population	0	15705	15588
DB Phase (Day 1 up to 7.2 Months) Non-FAS Post-Dose 1 Population	0	3	4
DB Phase (Day 1 up to 7.2 Months) FAS Post-Dose 1 Safety Subset (Subset of FAS)	0	3015	3052
DB Phase (Day 1 up to 7.2 Months) Non-FAS Post-Dose 1 Safety Subset (Subset of FAS)	0	1	0
DB Phase (Day 1 up to 7.2 Months) COMPLETED	0	15007	13834
DB Phase (Day 1 up to 7.2 Months) NOT COMPLETED	0	701	1758
DB + Open-label Phase (2 Years 6 Months) STARTED	31705	0	0
DB + Open-label Phase (2 Years 6 Months) COMPLETED	21018	0	0
DB + Open-label Phase (2 Years 6 Months) NOT COMPLETED	10687	0	0

Reasons for withdrawal

Measure	Combined Double-blind and Open-label Phase: All Participants Each participant was initially randomized to receive 1 dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, participants could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all participants were unblinded and entered OL phase, and those participants that received placebo could receive a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine for those participants that received a single dose of Ad26.COV2.S vaccine in the study.	Double Blind Phase: Ad26.COV2.S Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.
DB Phase (Day 1 up to 7.2 Months) Adverse Event	0	5	10
DB Phase (Day 1 up to 7.2 Months) Death	0	6	13
DB Phase (Day 1 up to 7.2 Months) Lost to Follow-up	0	170	219
DB Phase (Day 1 up to 7.2 Months) Physician Decision	0	15	6
DB Phase (Day 1 up to 7.2 Months) Pregnancy	0	0	1
DB Phase (Day 1 up to 7.2 Months) Protocol Violation	0	1	7
DB Phase (Day 1 up to 7.2 Months) Withdrawal by Subject	0	468	1273
DB Phase (Day 1 up to 7.2 Months) Initiated Prohibited Medication	0	10	75
DB Phase (Day 1 up to 7.2 Months) Rolled Over into Different Clinical Trial	0	0	3
DB Phase (Day 1 up to 7.2 Months) Technical Problems	0	0	2
DB Phase (Day 1 up to 7.2 Months) Other	0	26	149
DB + Open-label Phase (2 Years 6 Months) Adverse Event	14	0	0
DB + Open-label Phase (2 Years 6 Months) Death	131	0	0
DB + Open-label Phase (2 Years 6 Months) Lost to Follow-up	3796	0	0
DB + Open-label Phase (2 Years 6 Months) Physician Decision	178	0	0
DB + Open-label Phase (2 Years 6 Months) Pregnancy	2	0	0
DB + Open-label Phase (2 Years 6 Months) Protocol Violation	9	0	0
DB + Open-label Phase (2 Years 6 Months) Withdrawal by Subject	5922	0	0
DB + Open-label Phase (2 Years 6 Months) Initiated Prohibited Medication	92	0	0
DB + Open-label Phase (2 Years 6 Months) Rolled Over into Different Clinical Trial	48	0	0
DB + Open-label Phase (2 Years 6 Months) Technical Problems	17	0	0
DB + Open-label Phase (2 Years 6 Months) Sponsor Decision	1	0	0
DB + Open-label Phase (2 Years 6 Months) Other	477	0	0

Baseline Characteristics

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults

Baseline characteristics by cohort

Measure	Combined Double-blind and Open-label Phase: All Participants n=31705 Participants Each participant was initially randomized to receive 1 dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, participants could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all participants were unblinded and entered OL phase, and those participants that received placebo could receive a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine for those participants that received a single dose of Ad26.COV2.S vaccine in the study.
Age, Continuous	51.5 years STANDARD_DEVIATION 14.46 • n=5 Participants
Age, Customized From 18 to 64 years	25993 Participants n=5 Participants
Age, Customized From 65 to 84 years	5640 Participants n=5 Participants
Age, Customized 85 years and over	72 Participants n=5 Participants
Sex/Gender, Customized Female	15032 Participants n=5 Participants
Sex/Gender, Customized Male	16669 Participants n=5 Participants
Sex/Gender, Customized Undifferentiated	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	798 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2806 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2677 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	78 Participants n=5 Participants
Race/Ethnicity, Customized White	24074 Participants n=5 Participants
Race/Ethnicity, Customized More Than One Race	460 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	895 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	5799 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	25011 Participants n=5 Participants
Region of Enrollment BELGIUM	2981 Participants n=5 Participants
Region of Enrollment BRAZIL	500 Participants n=5 Participants
Region of Enrollment COLOMBIA	2149 Participants n=5 Participants
Region of Enrollment FRANCE	714 Participants n=5 Participants
Region of Enrollment GERMANY	100 Participants n=5 Participants
Region of Enrollment PHILIPPINES	1572 Participants n=5 Participants
Region of Enrollment SOUTH AFRICA	2073 Participants n=5 Participants
Region of Enrollment SPAIN	3132 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	5905 Participants n=5 Participants
Region of Enrollment UNITED STATES	12579 Participants n=5 Participants

PRIMARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: Per-protocol efficacy (PP) set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Participants With Onset at Least 14 Days After the Second Vaccination	14 Participants	52 Participants	—	—

SECONDARY outcome

Timeframe: From at least 1 day after first vaccination on Day 1 (Day 2) up to end of double blind phase (7.2 months)

Population: Full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration, regardless of protocol deviations and serostatus at enrollment.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=15708 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=15592 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset At Least 1 Day After the First Day 1 Vaccination	115 Participants	259 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: included participants of the FAS who received 2 doses of DB study vaccine, regardless of their serostatus at time of first vaccination and at 14 days after second vaccination, were PCR negative at time of first vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6813 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=6370 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Serostatus With Onset at Least 14 Days After the Second Vaccination	14 Participants	53 Participants	—	—

SECONDARY outcome

Timeframe: From at least 1 day after first vaccination on Day 1 (Day 2) up to end of double blind phase (7.2 months)

Population: Full analysis seronegative set included all randomized participants with at least 1 documented study vaccine administration, regardless of protocol deviations and who were seronegative at baseline.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=13951 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=13871 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Participants With Onset at Least 1 Day After the First Day 1 Vaccination	112 Participants	256 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after first vaccination on Day 1 (Day 15) up to end of double blind phase (7.2 months)

Population: Per-protocol first dose efficacy (PPFD) population: Participants in FAS who received at least first dose of study vaccine in the double-blind phase and who were PCR negative at the time of first vaccination, who were not seropositive at baseline and who had no major protocol deviations before unblinding that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Days 1 and 14 and participants who discontinued prior to Day 15 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=13316 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=13286 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 14 Days After the First Day 1 Vaccination	72 Participants	216 Participants	—	—

SECONDARY outcome

Timeframe: From at least 28 days after the first vaccination on Day 1 (Day 29) up to end of double blind phase (7.2 months)

Population: PPFD population: Participants in FAS who received at least first dose of study vaccine in the double-blind phase and who were PCR negative at the time of first vaccination, who were not seropositive at baseline and who had no major protocol deviations before unblinding that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 and participants who discontinued prior to Day 29 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=12632 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=12402 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Onset at Least 28 Days After the First Day 1 Vaccination	52 Participants	161 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention With Onset at Least 14 Days After the Second Vaccination	0 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: From Day 71 up to end of the COVID-19 episode (up to 90 days)

Population: PP set: participants in FAS who received 2 doses of double-blind study vaccine, were PCR negative at the time of first vaccination, were seronegative at the time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure.

AUC of SARS-CoV-2 viral load was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2. Due to change in the planned analysis, data was collected and analyzed for participants with molecularly confirmed symptomatic COVID-19 regardless of severity that is mild, moderate or severe and was not collected and analyzed separately for moderate to severe cases.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=11 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=47 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative RT-PCR in Participants With Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After Second Vaccination	847.68 Log10 copies*day per milliliter Standard Error 242.375	1023.59 Log10 copies*day per milliliter Standard Error 156.298	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 With Onset at Least 14 Days After the Second Vaccination	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US FDA Harmonized Case Definition With Onset at Least 14 Days After the Second Vaccination	12 Participants	52 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 With Onset at Least 14 Days After the Second Vaccination	14 Participants	53 Participants	—	—

SECONDARY outcome

Timeframe: From Day 71 up to unblinding visit (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

Number of participants with serologic conversion between Day 71 up to unblinding visit using an ELISA were reported. Due to change in planned analysis, data was collected and analyzed between Day 71 up to unblinding visit instead of from baseline to unblinding visit.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Serologic Conversion Between Day 71 up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)	32 Participants	45 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

Number of participants with asymptomatic infection detected by RT-PCR with onset at least 14 days after the second vaccination (Day 71) were reported.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) With Onset at Least 14 Days After the Second Vaccination	40 Participants	56 Participants	—	—

SECONDARY outcome

Timeframe: From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months)

Population: PP set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 were excluded.

Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after the second vaccination (Day 71) were reported.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=6024 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=5615 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) With Onset at Least 14 Days After the Second Vaccination	60 Participants	113 Participants	—	—

SECONDARY outcome

Timeframe: From Day 1 up to end of double blind phase (7.2 months)

Population: FAS post dose 1 population included FAS participants excluding the participants who received a COVID-19 vaccination outside of the study prior to first study vaccination.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=15705 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=15588 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Serious Adverse Events (SAEs)	104 Participants	136 Participants	—	—

SECONDARY outcome

Timeframe: From Day 1 up to end of double blind phase (7.2 months)

Population: FAS post dose 1 population included FAS participants excluding the participants who received a COVID-19 vaccination outside of the study prior to first study vaccination.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=15705 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=15588 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Adverse Events of Special Interest (AESIs)	2 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From Day 1 up to 7.2 months

Population: FAS post dose 1 population included FAS participants excluding the participants who received a COVID-19 vaccination outside of the study prior to first study vaccination.

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=15705 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=15588 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Medically-Attended Adverse Events (MAAEs)	1033 Participants	1003 Participants	—	—

SECONDARY outcome

Timeframe: From Day 1 up to end of double blind phase (7.2 months)

Population: FAS post dose 1 population included FAS participants excluding the participants who received a COVID-19 vaccination outside of the study prior to first study vaccination.

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=15705 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=15588 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double-Blind: Number of Participants With MAAEs Leading to Study Discontinuation	4 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64)

Population: Safety population was a subset of FAS for analyzing solicited local AEs. 'N' (overall number of participants analyzed) = participants evaluable for this outcome; 'n' (number analyzed) = participants evaluable at specific time points. N=0 in 'DB: Non-FAS Post-Dose 1: Placebo' arm, as no participant was evaluable in the FAS subset of this arm. n=0 in 'DB: Non-FAS Post-Dose 1' arm signifies the time point was not applicable since the participant did not receive a second vaccination.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=3015 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=3052 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S n=1 Participants Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination Day 8	1676 Participants	653 Participants	1 Participants	—
Double Blind Phase: Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination Day 64	896 Participants	252 Participants	—	—

SECONDARY outcome

Timeframe: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64)

Population: Safety population was subset of FAS for analysis of solicited systemic AEs. 'N' (overall number of participants analyzed)=participants evaluable for this outcome measure; 'n' (number analyzed)= participants evaluable at specified time points. N=0 in 'DB: Non-FAS Post-Dose 1: Placebo' arm, as no participant was evaluable in the FAS subset of this arm. n=0 in 'DB: Non-FAS Post-Dose 1' arm signifies the time point was not applicable since the participant did not receive a second vaccination.

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

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=3015 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=3052 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S n=1 Participants Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Solicited Systemic AEs During 7 Days Following Each Vaccination Day 8	1764 Participants	1138 Participants	1 Participants	—
Double Blind Phase: Number of Participants With Solicited Systemic AEs During 7 Days Following Each Vaccination Day 64	821 Participants	442 Participants	—	—

SECONDARY outcome

Timeframe: 28 days after first vaccination on Day 1 (up to Day 29), 28 days after second vaccination on Day 57 (up to Day 85)

Population: Safety population was subset of FAS for analysis of unsolicited AEs. 'N' (overall number of participants analyzed) = participants evaluable for this outcome measure; 'n' (number analyzed) = participants evaluable at specified time points. N=0 in 'DB: Non-FAS Post-Dose 1: Placebo' arm, as no participant was evaluable in the FAS subset of this arm. n=0 in 'DB: Non-FAS Post-Dose 1' arm signifies the time point was not applicable since the participant did not receive a second vaccination.

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=3015 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=3052 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S n=1 Participants Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: Number of Participants With Unsolicited Adverse Events (AEs) During 28 Days Post Each Vaccination Day 29	454 Participants	332 Participants	0 Participants	—
Double Blind Phase: Number of Participants With Unsolicited Adverse Events (AEs) During 28 Days Post Each Vaccination Day 85	159 Participants	120 Participants	—	—

SECONDARY outcome

Timeframe: At Baseline (Day 1), Days 29, 57 and 71

Population: Per protocol immunogenicity (PPI) set: all randomized and vaccinated participants (received both vaccines in DB phase, including those who were part of immunogenicity subset and for whom immunogenicity data were available, excluding participants with major protocol deviations expected to impact immunogenicity outcomes. N (overall number of participants analyzed) = participants evaluated for this outcome measure, n (number analyzed) = number of participants evaluable at specified time points.

Binding antibodies to SARS-CoV-2 S protein as assessed by ELISA to measure humoral immune response was reported. The lower limit of quantification (LLOQ) was 50.3 ELISA units per milliliter (EU/mL). A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).

Outcome measures

Measure	Double Blind Phase: Ad26.COV2.S n=157 Participants Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=149 Participants Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.
Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA Day 1	NA ELISA Unit/milliliter (EU/mL) Geometric mean and 95% confidence interval could not be estimated as the analyzed values were below the LLOQ (50.3 EU/mL).	NA ELISA Unit/milliliter (EU/mL) Geometric mean and 95% confidence interval could not be estimated as the analyzed values were below the LLOQ (50.3 EU/mL).	—	—
Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA Day 29	367 ELISA Unit/milliliter (EU/mL) Interval 295.0 to 456.0	NA ELISA Unit/milliliter (EU/mL) Geometric mean and 95% confidence interval could not be estimated as the analyzed values were below the LLOQ (50.3 EU/mL).	—	—
Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA Day 57	518 ELISA Unit/milliliter (EU/mL) Interval 422.0 to 635.0	NA ELISA Unit/milliliter (EU/mL) Geometric mean and 95% confidence interval could not be estimated as the analyzed values were below the LLOQ (50.3 EU/mL).	—	—
Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA Day 71	2220 ELISA Unit/milliliter (EU/mL) Interval 1794.0 to 2748.0	NA ELISA Unit/milliliter (EU/mL) Geometric mean and 95% confidence interval could not be estimated as the analyzed values were below the LLOQ (50.3 EU/mL).	—	—

Adverse Events

Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Double Blind Phase: Non-FAS Post-Dose 1: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Blind Phase: Ad26.COV2.S

Serious events: 104 serious events

Other events: 2234 other events

Deaths: 6 deaths

Double Blind Phase: Placebo

Serious events: 136 serious events

Other events: 1531 other events

Deaths: 13 deaths

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

Serious events: 1583 serious events

Other events: 0 other events

Deaths: 131 deaths

Serious adverse events

Measure	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S n=1 participants at risk；n=3 participants at risk Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo n=4 participants at risk Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Ad26.COV2.S n=3015 participants at risk；n=15705 participants at risk Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=3052 participants at risk；n=15588 participants at risk Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Combined Double-blind and Open-label Phase: All Participants n=31705 participants at risk Each participant was initially randomized to receive 1 dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, participants could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all participants were unblinded and entered OL phase, and those participants that received placebo could receive a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine for those participants that received a single dose of Ad26.COV2.S vaccine in the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 10/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Anaemia megaloblastic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Nephrogenic anaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Splenic vein thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.06% 18/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.11% 36/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Angina pectoris	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 14/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Angina unstable	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Aortic valve disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Aortic valve incompetence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Aortic valve stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Arrhythmia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Arteriospasm coronary	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.09% 27/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrial flutter	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrial tachycardia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrioventricular block	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrioventricular block complete	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Atrioventricular block second degree	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Bradycardia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Bundle branch block left	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardiac arrest	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardiac disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardiac failure	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardiac failure acute	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 12/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cardiovascular disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Cor pulmonale	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Coronary artery disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.06% 18/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Coronary artery occlusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Coronary artery stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 11/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Extrasystoles	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Heart valve incompetence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Microvascular coronary artery disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Mitral valve disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Mitral valve incompetence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Myocardial fibrosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Myocardial infarction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 4/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.08% 24/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Myocardial ischaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Myocarditis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Palpitations	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Pericardial effusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Pericarditis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Sinus node dysfunction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Tachycardia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Ventricular arrhythmia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Ventricular fibrillation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Cardiac disorders Ventricular tachycardia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Congenital, familial and genetic disorders Brugada syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Congenital, familial and genetic disorders Congenital tracheomalacia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Congenital, familial and genetic disorders Laryngocele	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Congenital, familial and genetic disorders Phimosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Basedow's disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Goitre	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Hypothyroidism	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Parathyroid disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Thyroid cyst	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Endocrine disorders Thyroiditis acute	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Blindness transient	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Cataract	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Diplopia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Epiretinal membrane	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Glaucoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Retinal detachment	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Retinal ischaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Scleritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Uveitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Eye disorders Vitreous detachment	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Anal fistula	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Appendicitis noninfective	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Colitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Constipation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Crohn's disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Diverticular perforation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Diverticulum	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Duodenitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Enteritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Enterocele	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Epiploic appendagitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Femoral hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Hiatus hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Ileus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Inguinal hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.05% 16/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Intestinal perforation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Intestinal prolapse	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Intestinal strangulation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Intestinal ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Large intestine polyp	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Lumbar hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Nausea	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Obstructive defaecation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Peptic ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Peritoneal hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Retroperitoneal mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Salivary gland mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Umbilical hernia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Varices oesophageal	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Gastrointestinal disorders Vomiting	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Accidental death	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Capsular contracture associated with implant	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Chest discomfort	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Chest pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Death	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.06% 19/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Death neonatal	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Gait disturbance	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Hernia pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Injection site swelling	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Malaise	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Non-cardiac chest pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Oedema peripheral	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Pyrexia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Sudden death	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Vaccination site pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Vascular stent stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Bile duct stone	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Biliary cyst	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 10/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.06% 19/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Hepatic cyst	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Hydrocholecystis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Jaundice	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Immune system disorders Allergy to vaccine	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Immune system disorders Anaphylactic reaction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Immune system disorders Food allergy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Abdominal wall abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Abscess jaw	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Abscess limb	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Anal abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Appendiceal abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Appendicitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 4/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.11% 34/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Appendicitis perforated	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Arboviral infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Arthritis bacterial	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Aspergilloma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Bacterial sepsis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Bartholinitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Burn infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Bursitis infective	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations COVID-19	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 5/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.15% 24/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.25% 78/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations COVID-19 pneumonia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.08% 13/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.14% 45/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Catheter site infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Cellulitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.05% 15/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Cholecystitis infective	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Chronic hepatitis B	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Colonic abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Complicated appendicitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Cystitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Cytomegalovirus infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Dengue fever	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Device related infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Diabetic foot infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Disseminated tuberculosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Diverticulitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Encephalitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Erysipelas	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Escherichia pyelonephritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Escherichia urinary tract infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Eye infection intraocular	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Gangrene	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Gastric ulcer helicobacter	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Gastritis helminthic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Gastroenteritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Gastroenteritis norovirus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations HIV infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Herpes zoster	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Infected bite	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Infectious mononucleosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Intervertebral discitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Kidney infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Laryngitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Localised infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Lung abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Lymphangitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Meningitis viral	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Murine typhus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Neurosyphilis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Orchitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Osteomyelitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pelvic inflammatory disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Peritonitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Plasmodium falciparum infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumococcal sepsis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.14% 45/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia aspiration	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia bacterial	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia pneumococcal	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia pseudomonal	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia staphylococcal	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pneumonia viral	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Post procedural infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pseudomonas infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pulmonary tuberculosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pyelonephritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Pyelonephritis acute	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Sepsis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.07% 22/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Septic shock	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Shunt infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Sialoadenitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Sinusitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Spontaneous bacterial peritonitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Streptococcal bacteraemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Submandibular abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Suspected COVID-19	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Systemic candida	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Tonsillitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Tubo-ovarian abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Urinary tract infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 14/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Urinary tract infection bacterial	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Urosepsis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 10/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Vestibular neuronitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Viral infection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Wound sepsis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Anaesthetic complication	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Anaphylactic transfusion reaction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Animal bite	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Avulsion fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Bone graft lysis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Chest injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Frostbite	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Head injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Joint injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Lisfranc fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Neck injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Osteoradionecrosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Poisoning	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 12/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Seroma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Snake bite	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 9/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Traumatic arthrosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Biopsy liver	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Cardiac murmur	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Electrocardiogram ST segment depression	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Heart rate irregular	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Myocardial necrosis marker increased	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Sleep study	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Investigations Troponin increased	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Adult failure to thrive	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Gout	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Obesity	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Chondrolysis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 9/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Infrapatellar fat pad inflammation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.05% 16/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Jaw disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Meniscopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.22% 70/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Vertebral lateral recess stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal neoplasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of testis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline serous tumour of ovary	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.07% 22/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial neoplasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian tube cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma stage III	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage 0	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 6/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage I	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma stage III	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of nipple	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phyllodes tumour	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.09% 29/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal cord neoplasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vulva	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour of ampulla of Vater	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Aphasia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Ataxia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Bell's palsy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Brain injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Brain oedema	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Carotid artery stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cauda equina syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebellar infarction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebellar stroke	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebral amyloid angiopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebral infarction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebral thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 12/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cervical radiculopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Cognitive disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Diabetic ketoacidotic hyperglycaemic coma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Dizziness	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Dysarthria	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Epilepsy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Facial paresis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Haemorrhagic stroke	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Hashimoto's encephalopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Headache	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Hemiparesis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Hypoglossal nerve paresis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Intracranial aneurysm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Intracranial mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Ischaemic stroke	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 12/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Lacunar stroke	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Loss of consciousness	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Lumbar radiculopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Memory impairment	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Metabolic encephalopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Migraine	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Myelitis transverse	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Myelopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Neuralgia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Neuromyopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Nystagmus	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Paresis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Partial seizures	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Peroneal nerve palsy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Post-traumatic epilepsy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Presyncope	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Primary headache associated with sexual activity	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Pseudostroke	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Radiculopathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders SUNCT syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Sciatica	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 8/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Seizure	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Spinal claudication	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Syncope	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 11/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Tension headache	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Thalamic infarction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Transient global amnesia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 14/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 9/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions HELLP syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Product Issues Device dislocation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Product Issues Device failure	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Product Issues Prosthetic cardiac valve malfunction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Acute psychosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Affective disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Alcoholism	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Anxiety	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Bipolar I disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Bipolar disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Completed suicide	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Confusional state	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Conversion disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Delirium	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Depression	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 10/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Depression suicidal	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Drug abuse	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Gender dysphoria	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Intentional self-injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Nicotine dependence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Psychiatric decompensation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Psychotic disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Schizoaffective disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Schizoaffective disorder bipolar type	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Schizophrenia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Suicidal ideation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Psychiatric disorders Suicide attempt	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 10/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Calculus bladder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Calculus urinary	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders End stage renal disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 3/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.05% 15/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Renal colic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Renal cyst	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Renal failure	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Renal impairment	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Renal mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urate nephropathy	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Ureterolithiasis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urethral obstruction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urethral stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urinary retention	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Adnexal torsion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Breast discomfort	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Breast enlargement	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Breast mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Colpocele	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Cystocele	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Endometriosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 7/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Ovarian disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Pelvic fluid collection	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Prostatitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Rectocele	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Reproductive system and breast disorders Vulvar dysplasia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.04% 12/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 10/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Neonatal dyspnoea	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pharyngeal haematoma	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 4/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.11% 35/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Social circumstances Bereavement	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Social circumstances Homicide	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Social circumstances Miscarriage of partner	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aneurysm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aneurysm thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aortic aneurysm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aortic aneurysm rupture	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aortic dilatation	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aortic stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Aortic thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Arteriosclerosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 4/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Circulatory collapse	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.03% 9/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Essential hypertension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Hypertension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.02% 5/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Hypertensive crisis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Hypertensive urgency	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Hypotension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 3/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Hypovolaemic shock	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Iliac artery stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Intermittent claudication	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Malignant hypertension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Microscopic polyangiitis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Penetrating aortic ulcer	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral artery aneurysm	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral artery occlusion	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral artery stenosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral artery thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral embolism	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Peripheral venous disease	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Shock	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Superficial vein thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Systolic hypertension	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Varicose vein	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 1/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Venous thrombosis	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Vascular disorders Venous thrombosis limb	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 2/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Fatigue	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Unevaluable event	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Infections and infestations Postoperative abscess	0.00% 0/3 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/4 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.01% 1/15705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/15588 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.00% 0/31705 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.

Other adverse events

Measure	Double Blind Phase: Non-FAS Post-Dose 1: Ad26.COV2.S n=1 participants at risk；n=3 participants at risk Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Non-FAS Post-Dose 1: Placebo n=4 participants at risk Participants who received a COVID-19 vaccination outside of the study prior to first study vaccination were randomized to receive a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1.	Double Blind Phase: Ad26.COV2.S n=3015 participants at risk；n=15705 participants at risk Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57.	Double Blind Phase: Placebo n=3052 participants at risk；n=15588 participants at risk Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57.	Combined Double-blind and Open-label Phase: All Participants n=31705 participants at risk Each participant was initially randomized to receive 1 dose of 0.5 mL Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and on Day 57 or 1 dose of placebo vaccine intramuscularly on Day 1 and on Day 57 during the DB phase (up to 7.2 months). Following authorization of COVID-19 vaccine(s) in their country, participants could request to be unblinded to receive a different authorized/licensed COVID-19 vaccine outside of the study at any time during the study. Following Emergency Use Authorization of Ad26.COV2.S in the United States, all participants were unblinded and entered OL phase, and those participants that received placebo could receive a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine. Later it was allowed to have a booster vaccination with a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine for those participants that received a single dose of Ad26.COV2.S vaccine in the study.
Gastrointestinal disorders Nausea(Solicited)	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	22.1% 666/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	12.7% 387/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Fatigue(Solicited)	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	50.8% 1531/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	29.4% 897/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Pyrexia(Solicited)	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	5.9% 177/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.59% 18/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Vaccination site erythema(Solicited)	100.0% 1/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	10.3% 311/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	5.6% 170/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Vaccination site pain	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	2.4% 72/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	0.75% 23/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Vaccination site pain(Solicited)	100.0% 1/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	60.3% 1818/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	21.8% 664/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Vaccination site swelling(Solicited)	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	7.1% 215/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	2.1% 65/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Myalgia(Solicited)	100.0% 1/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	44.6% 1346/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	18.7% 572/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Headache(Solicited)	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	47.5% 1432/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	28.6% 873/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
General disorders Fatigue	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	4.2% 128/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	3.9% 119/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	3.3% 99/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	2.8% 86/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.
Nervous system disorders Headache	0.00% 0/1 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	4.6% 138/3015 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	3.9% 120/3052 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.	— 0/0 • DB phase: All-cause mortality and SAEs: From Day 1 till end of DB phase (up to 7.2 months), Solicited AEs: 7 days after first vaccination on Day 1 (up to Day 8), 7 days after second vaccination on Day 57 (up to Day 64) ; All participants arm: All-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6 months); DB Phase: Other AEs: 28 days after first vaccination on Day 1 (up to Day 29 ), 28 days after vaccination 2 on Day 57 (up to Day 85) All-cause mortality/SAE: Per change in planned analysis, due to complex vaccination schedules, combined data for DB and OL was analyzed in the 'All Participant' arm after unblinding. As pre-specified: (a) only deaths/SAEs were planned to be collected in OL phase, (b) safety subset of FAS was used to analyze other AEs in DB phase. At risk=0 for 'All Participant' arm for other AEs as data for other AEs was not collected after unblinding (end of DB phase) per planned analysis. DB: MedDRA v24.0.

Additional Information

VICE PRESIDENT Medical Affairs IDV

Janssen Vaccines & Prevention B.V.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
• Publication restrictions are in place

Restriction type: OTHER