Trial Outcomes & Findings for A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older (NCT NCT05566639)

NCT ID: NCT05566639

Last Updated: 2025-01-16

Results Overview

Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 22502 participants
• Primary outcome timeframe: 7 days post-vaccination
• Results posted on: 2025-01-16

Participant Flow

A total of 22502 participants were randomized in this study, including 11252 participants in the mRNA-1010 group and 11250 participants in the Fluarix Quadrivalent group.

Participant milestones

Measure	Fluarix Quadrivalent Participants received a single dose of Fluarix Quadrivalent by intramuscular (IM) injection on Day 1.	mRNA-1010 Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Overall Study STARTED	11250	11252
Overall Study Full Analysis Set	11199	11211
Overall Study Safety Set	11200	11210
Overall Study Solicited Safety Set	11160	11168
Overall Study Per-Protocol (PP) Set	11026	11055
Overall Study PP Immunogenicity Set (PPIS)	408	444
Overall Study COMPLETED	10359	10359
Overall Study NOT COMPLETED	891	893

Reasons for withdrawal

Measure	Fluarix Quadrivalent Participants received a single dose of Fluarix Quadrivalent by intramuscular (IM) injection on Day 1.	mRNA-1010 Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Overall Study Adverse Event	1	1
Overall Study Serious Adverse Event	1	3
Overall Study Death	44	45
Overall Study Lost to Follow-up	467	461
Overall Study Physician Decision	45	44
Overall Study Protocol Deviation	4	4
Overall Study Withdrawal by Subject	277	271
Overall Study Other Than Specified	52	64

Baseline Characteristics

A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older

Baseline characteristics by cohort

Measure	Fluarix Quadrivalent n=11250 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11252 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.	Total n=22502 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 8.41 • n=5 Participants	63.9 years STANDARD_DEVIATION 8.36 • n=7 Participants	63.9 years STANDARD_DEVIATION 8.39 • n=5 Participants
Sex: Female, Male Female	6281 Participants n=5 Participants	6256 Participants n=7 Participants	12537 Participants n=5 Participants
Sex: Female, Male Male	4969 Participants n=5 Participants	4996 Participants n=7 Participants	9965 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1837 Participants n=5 Participants	1859 Participants n=7 Participants	3696 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9289 Participants n=5 Participants	9273 Participants n=7 Participants	18562 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	124 Participants n=5 Participants	120 Participants n=7 Participants	244 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) Asian	280 Participants n=5 Participants	254 Participants n=7 Participants	534 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1986 Participants n=5 Participants	1950 Participants n=7 Participants	3936 Participants n=5 Participants
Race (NIH/OMB) White	8790 Participants n=5 Participants	8850 Participants n=7 Participants	17640 Participants n=5 Participants
Race (NIH/OMB) More than one race	37 Participants n=5 Participants	48 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	87 Participants n=5 Participants	82 Participants n=7 Participants	169 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days post-vaccination

Population: Solicited Safety Set included all randomized participants who received any study intervention and contributed to any solicited AR data.

Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Measure	Fluarix Quadrivalent n=11160 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11168 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 3	245 Participants	500 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Any	5620 Participants	7989 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 1	3840 Participants	4433 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 2	1535 Participants	3050 Participants
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Grade 4	0 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to 28 days post-vaccination

Population: Safety Set included all randomized participants who received any study intervention. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.

Outcome measures

Measure	Fluarix Quadrivalent n=11200 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11210 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Unsolicited Adverse Events (AEs)	1495 Participants	1351 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 361 (Month 12)

Population: Safety Set included all randomized participants who received any study intervention. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 [COVID-19] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 361) are reported in this outcome measure.

Outcome measures

Measure	Fluarix Quadrivalent n=11200 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11210 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation SAEs	495 Participants	518 Participants
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation AESIs	13 Participants	10 Participants
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation MAAEs	3166 Participants	3126 Participants
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation AEs Leading to Discontinuation	47 Participants	49 Participants

PRIMARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: Per-Protocol (PP) Set included all participants in the Modified Intent-to-Treat (mITT) Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

Protocol-defined ILI: The presence of body temperature ≥37.5 degrees celsius (°C) (≥99.5 degrees fahrenheit [°F]), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive Reverse Transcription Polymerase Chain Reaction (RT-PCR) for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	142 Participants	140 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: As pre-specified, the data for this outcome measure was not collected and analyzed.

Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Influenza A or B Strains Antigenically Matched to the Vaccine Strains Selected for the Seasonal Vaccine	85 Participants	75 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains	70 Participants	70 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: As pre-specified, the data for this outcome measure was not collected and analyzed.

CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of RT-PCR CDC-Defined ILI Caused by Influenza A or B Strains That Were Antigenically Matched to Vaccine Strains	44 Participants	38 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	91 Participants	81 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

CDC-defined ILI: The presence of temperature ≥37.8°C [≥100°F], accompanied by at least one of the respiratory illness symptoms (cough and/or sore throat) and a positive RT-PCR for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	45 Participants	40 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination through Day 181 (Month 6)

Population: PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention.

Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza.

Outcome measures

Measure	Fluarix Quadrivalent n=11026 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11055 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 29

Population: PP Immunogenicity Set (PPIS) included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% confidence interval (CI) was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.

Outcome measures

Measure	Fluarix Quadrivalent n=408 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=444 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Yamagata Lineage	140.50 titer Interval 127.49 to 154.85	132.24 titer Interval 121.25 to 144.23
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza A H1N1 Antibody	105.34 titer Interval 95.71 to 115.93	149.14 titer Interval 135.47 to 164.19
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza A H3N2 Antibody	85.99 titer Interval 77.64 to 95.23	104.06 titer Interval 94.35 to 114.77
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Victoria Lineage	176.63 titer Interval 162.42 to 192.08	139.91 titer Interval 129.71 to 150.91

SECONDARY outcome

Timeframe: Day 29

Population: PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

Seroconversion was defined as either a Baseline HAI titer <1:10 and a post-Baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-Baseline HAI antibody titer.

Outcome measures

Measure	Fluarix Quadrivalent n=408 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=444 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H1N1 Antibody	29.4 percentage of participants Interval 25.03 to 34.09	44.8 percentage of participants Interval 40.13 to 49.58
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H3N2 Antibody	39.7 percentage of participants Interval 34.93 to 44.64	52.0 percentage of participants Interval 47.27 to 56.76
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Yamagata Lineage	27.5 percentage of participants Interval 23.18 to 32.06	26.6 percentage of participants Interval 22.52 to 30.95
Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Victoria Lineage	22.8 percentage of participants Interval 18.81 to 27.18	13.1 percentage of participants Interval 10.07 to 16.56

SECONDARY outcome

Timeframe: Day 29

Population: PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

Outcome measures

Measure	Fluarix Quadrivalent n=408 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=444 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza A H1N1 Antibody	90.0 percentage of participants Interval 86.61 to 92.69	94.4 percentage of participants Interval 91.8 to 96.32
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza A H3N2 Antibody	85.5 percentage of participants Interval 81.75 to 88.81	89.6 percentage of participants Interval 86.42 to 92.31
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza B/ Yamagata Lineage	94.6 percentage of participants Interval 91.95 to 96.59	94.8 percentage of participants Interval 92.33 to 96.69
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29 Influenza B/ Victoria Lineage	98.3 percentage of participants Interval 96.5 to 99.31	98.0 percentage of participants Interval 96.19 to 99.07

SECONDARY outcome

Timeframe: Baseline, Day 29

Population: PPIS included all randomized participants in the biomarker subset who received any study intervention; had baseline and Day 29 antibody assessment via HAI assay; complied with the immunogenicity testing schedule, and had no major protocol deviations that impacted the immunogenicity assessment.

The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% CI for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.

Outcome measures

Measure	Fluarix Quadrivalent n=408 Participants Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=444 Participants Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H1N1 Antibody	2.42 ratio Interval 2.22 to 2.64	3.42 ratio Interval 3.13 to 3.73
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza A H3N2 Antibody	3.04 ratio Interval 2.79 to 3.3	3.74 ratio Interval 3.44 to 4.07
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Yamagata Lineage	2.46 ratio Interval 2.26 to 2.69	2.28 ratio Interval 2.14 to 2.43
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains Influenza B/ Victoria Lineage	2.07 ratio Interval 1.92 to 2.24	1.75 ratio Interval 1.65 to 1.85

Adverse Events

Fluarix Quadrivalent

Serious events: 495 serious events

Other events: 603 other events

Deaths: 44 deaths

mRNA-1010

Serious events: 518 serious events

Other events: 572 other events

Deaths: 45 deaths

Serious adverse events

Measure	Fluarix Quadrivalent n=11200 participants at risk Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11210 participants at risk Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Infections and infestations Abdominal abscess	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Abdominal sepsis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Abscess limb	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Appendicitis	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Appendicitis perforated	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Arthritis bacterial	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Bacterial sepsis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Bronchitis	0.03% 3/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations COVID-19	0.07% 8/11200 • Number of events 8 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.07% 8/11210 • Number of events 8 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations COVID-19 pneumonia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Cellulitis	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.08% 9/11210 • Number of events 11 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Cellulitis staphylococcal	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Cholecystitis infective	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Clostridium difficile colitis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Clostridium difficile infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Colonic abscess	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Complicated appendicitis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Device related bacteraemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Device related infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Diverticulitis	0.06% 7/11200 • Number of events 7 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Endocarditis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Epstein-Barr virus infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Escherichia infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Gangrene	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Gastroenteritis	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Gastroenteritis viral	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Human anaplasmosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Influenza	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Intervertebral discitis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Kidney infection	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Klebsiella infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Localised infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Meningitis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Metapneumovirus infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Oral candidiasis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Osteomyelitis	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Parainfluenzae viral bronchitis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Periorbital cellulitis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Perirectal abscess	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Peritonitis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pharyngitis streptococcal	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pharyngolaryngeal abscess	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pilonidal disease	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pneumonia	0.19% 21/11200 • Number of events 21 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.19% 21/11210 • Number of events 22 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pneumonia aspiration	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pneumonia bacterial	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pneumonia chlamydial	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Post procedural infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Post procedural sepsis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Postoperative abscess	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Postoperative wound infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Prostatitis Escherichia coli	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pyelonephritis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Pyelonephritis acute	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Rectal abscess	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Respiratory syncytial virus infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Respiratory tract infection	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Rhinovirus infection	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Scrotal abscess	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Sepsis	0.08% 9/11200 • Number of events 9 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.11% 12/11210 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Septic shock	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Soft tissue infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Staphylococcal skin infection	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Tularaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Urinary tract infection	0.05% 6/11200 • Number of events 6 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.10% 11/11210 • Number of events 11 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Urosepsis	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Viral infection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Vulval cellulitis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Infections and infestations Wound infection	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign laryngeal neoplasm	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of testis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign uterine neoplasm	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.07% 8/11200 • Number of events 8 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.05% 6/11210 • Number of events 6 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous T-cell lymphoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epiglottic cancer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lobular breast carcinoma in situ	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Primary myelofibrosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.11% 12/11200 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma of the cervix	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine neuroendocrine tumour	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer stage 0	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Anaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Blood loss anaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Leukocytosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Methaemoglobinaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Blood and lymphatic system disorders Thrombocytosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Immune system disorders Anaphylactic reaction	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Immune system disorders Drug hypersensitivity	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Endocrine disorders Goitre	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Endocrine disorders Hyperparathyroidism	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Endocrine disorders Hyperthyroidism	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Endocrine disorders Primary hyperaldosteronism	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Alcoholic ketoacidosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Dehydration	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Diabetic complication	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.02% 2/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Fluid retention	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypercalcaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hyperglycaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.02% 2/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hyperkalaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypervolaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypoglycaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypokalaemia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypomagnesaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hyponatraemia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Hypovolaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Lactic acidosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Malnutrition	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Obesity	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Steroid diabetes	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.02% 2/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Acute psychosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Affective disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Alcohol abuse	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Alcohol use disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Anxiety	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Bipolar disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Completed suicide	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Confusional state	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Delirium	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Depression	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Depression suicidal	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Drug dependence	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Major depression	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Mental status changes	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Mixed anxiety and depressive disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Post-traumatic stress disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Psychotic disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Schizoaffective disorder	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Substance abuse	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Psychiatric disorders Suicidal ideation	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Carotid artery disease	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Carotid artery occlusion	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Carotid artery stenosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebellar infarction	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebellar stroke	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebral artery embolism	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebral infarction	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebral venous sinus thrombosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebral ventricle dilatation	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cerebrovascular accident	0.12% 14/11200 • Number of events 14 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.14% 16/11210 • Number of events 16 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cervical radiculopathy	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Cranial nerve paralysis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Dementia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Dementia Alzheimer's type	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Dizziness	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Embolic stroke	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Encephalopathy	0.02% 2/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Haemorrhagic stroke	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Hemiparesis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Hypoaesthesia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Ischaemic stroke	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Lacunar infarction	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Lacunar stroke	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Lumbar radiculopathy	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Metabolic encephalopathy	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Migraine with aura	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Multiple sclerosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Multiple sclerosis relapse	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Myelopathy	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Nerve compression	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Paraesthesia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Piriformis syndrome	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Post herpetic neuralgia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Presyncope	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Radial nerve palsy	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Sciatica	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Seizure	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Spinal cord disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Spinal cord haematoma	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Spinal meningeal cyst	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Status epilepticus	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Syncope	0.05% 6/11200 • Number of events 7 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Transient global amnesia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Transient ischaemic attack	0.05% 6/11200 • Number of events 6 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Tremor	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Nervous system disorders Vertebrobasilar stroke	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Eye disorders Disorder of orbit	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Eye disorders Retinal artery occlusion	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Eye disorders Vision blurred	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Eye disorders Vitreous haemorrhage	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Ear and labyrinth disorders Vertigo	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Ear and labyrinth disorders Vertigo positional	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Acute left ventricular failure	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Acute myocardial infarction	0.10% 11/11200 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.11% 12/11210 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Angina pectoris	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Angina unstable	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Aortic valve incompetence	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Aortic valve stenosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Arrhythmia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Atrial fibrillation	0.12% 14/11200 • Number of events 15 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.14% 16/11210 • Number of events 19 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Atrial flutter	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Atrioventricular block	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Bradycardia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiac arrest	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiac disorder	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiac failure	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiac failure acute	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiac failure chronic	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiac failure congestive	0.09% 10/11200 • Number of events 11 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.10% 11/11210 • Number of events 14 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardio-respiratory arrest	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiogenic shock	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiomyopathy	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Cardiopulmonary failure	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Coronary artery aneurysm	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Coronary artery disease	0.08% 9/11200 • Number of events 9 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.07% 8/11210 • Number of events 8 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Coronary artery dissection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Coronary artery occlusion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Coronary artery stenosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Intracardiac thrombus	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Left ventricular failure	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Mitral valve incompetence	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Mitral valve prolapse	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Myocardial infarction	0.08% 9/11200 • Number of events 9 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.11% 12/11210 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Myocardial ischaemia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Myocarditis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Myopericarditis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Pericardial effusion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Pericarditis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Sinus arrhythmia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Sinus node dysfunction	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Supraventricular tachycardia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Tachycardia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Ventricular arrhythmia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Cardiac disorders Ventricular tachycardia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Aortic aneurysm	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Aortic dissection	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Aortic stenosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Arteriosclerosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Deep vein thrombosis	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Dry gangrene	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Embolism	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Giant cell arteritis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Hypertension	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Hypertensive crisis	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Hypertensive emergency	0.01% 1/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Hypertensive urgency	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Hypotension	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Peripheral arterial occlusive disease	0.03% 3/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Peripheral artery occlusion	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Peripheral artery stenosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Peripheral artery thrombosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Peripheral ischaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Peripheral vascular disorder	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Shock	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Vascular disorders Vascular stenosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.09% 10/11200 • Number of events 11 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.07% 8/11210 • Number of events 11 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Asthma	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.12% 14/11200 • Number of events 14 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.17% 19/11210 • Number of events 25 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Cough	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.11% 12/11200 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.07% 8/11210 • Number of events 8 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Abdominal adhesions	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Abdominal discomfort	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Abdominal hernia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Abdominal pain	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 6 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Ascites	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Colitis	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Constipation	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Diarrhoea	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Diverticular perforation	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Diverticulum intestinal	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Duodenal ulcer perforation	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Duodenitis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Enteritis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Gastric ulcer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Gastritis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Gastritis alcoholic	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Gastrointestinal disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Hiatus hernia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Ileus	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Impaired gastric emptying	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Inguinal hernia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Intestinal mass	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Intestinal obstruction	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Intestinal perforation	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Intussusception	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Large intestine perforation	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Large intestine polyp	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Melaena	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Nausea	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Oesophagitis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Pancreatitis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Pancreatitis acute	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Pancreatitis chronic	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Small intestinal obstruction	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.06% 7/11210 • Number of events 7 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Small intestinal perforation	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Umbilical hernia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Umbilical hernia perforation	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Volvulus	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Gastrointestinal disorders Vomiting	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Bile duct stone	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Biliary colic	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Cholangitis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Cholecystitis	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Cholecystitis acute	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Cholelithiasis	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Hepatic failure	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Hepatobiliary disorders Hepatorenal failure	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Skin and subcutaneous tissue disorders Angioedema	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Skin and subcutaneous tissue disorders Excessive skin	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Skin and subcutaneous tissue disorders Skin lesion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Back pain	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Bone demineralisation	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Exostosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Foot deformity	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Muscle spasms	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Neck pain	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.20% 22/11200 • Number of events 22 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.11% 12/11210 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Acute kidney injury	0.12% 14/11200 • Number of events 15 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.11% 12/11210 • Number of events 12 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Bladder stenosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Calculus urinary	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Chronic kidney disease	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Hydronephrosis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Nephrolithiasis	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 6 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Renal cyst	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Renal failure	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Renal impairment	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Stress urinary incontinence	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Ureterolithiasis	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Renal and urinary disorders Urinary retention	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Asthenia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Chest discomfort	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Chest pain	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Death	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.07% 8/11210 • Number of events 8 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Drug withdrawal syndrome	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Generalised oedema	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Non-cardiac chest pain	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 5/11210 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Oedema peripheral	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Pain	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Pyrexia	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Stent-graft endoleak	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Strangulated hernia	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
General disorders Sudden death	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Blood potassium decreased	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Hepatic enzyme abnormal	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Hepatic enzyme increased	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations International normalised ratio abnormal	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Liver function test abnormal	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Prostatic specific antigen increased	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Troponin increased	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations Weight increased	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Investigations White blood cell count increased	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Accidental overdose	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Acetabulum fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Alcohol poisoning	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Anastomotic ulcer	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Animal bite	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Ankle fracture	0.03% 3/11200 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Bronchitis chemical	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Concussion	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Contusion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Fall	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Femoral nerve injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Femur fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Fibula fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Foot fracture	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Forearm fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Fracture displacement	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Gun shot wound	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Head injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Heat exhaustion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Hip fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.04% 4/11210 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Limb crushing injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Limb injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Multiple injuries	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Overdose	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Patella fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Periprosthetic fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Post procedural complication	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Procedural pain	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Rib fracture	0.04% 5/11200 • Number of events 5 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.03% 3/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Road traffic accident	0.04% 4/11200 • Number of events 4 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Sacroiliac fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Skin abrasion	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Skin laceration	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Snake bite	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Spinal compression fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Spinal fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Splenic rupture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Subdural haematoma	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Tendon rupture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Tibia fracture	0.02% 2/11200 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Transplant failure	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Traumatic haemothorax	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Traumatic liver injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Traumatic lung injury	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Ulna fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Upper limb fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.02% 2/11210 • Number of events 2 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/11200 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.01% 1/11210 • Number of events 3 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.
Injury, poisoning and procedural complications Wrist fracture	0.01% 1/11200 • Number of events 1 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	0.00% 0/11210 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

Other adverse events

Measure	Fluarix Quadrivalent n=11200 participants at risk Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1.	mRNA-1010 n=11210 participants at risk Participants received a single dose of mRNA-1010 by IM injection on Day 1.
Infections and infestations COVID-19	5.4% 603/11200 • Number of events 621 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.	5.1% 572/11210 • Number of events 581 • Day 1 up to the end of the study (Day 361) The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to the study intervention that they actually received.

Additional Information

Moderna Clinical Trials Support Center

ModernaTX, Inc.

Phone: 1-877-777-7187

Email: clinicaltrials@modernatx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place