Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 (NCT NCT05249829)

NCT ID: NCT05249829

Last Updated: 2024-08-09

Results Overview

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as absorbance units/millilitre (AU/mL). The GMC 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 3548 participants
• Primary outcome timeframe: Day 29 (post vaccination)
• Results posted on: 2024-08-09

Participant Flow

Of the 3779 participants who were screened for Part 1 and Part 2 of the study, 220 participants failed screening and 11 did not receive study vaccine.

Participant milestones

Measure	Part 1: mRNA-1273.529 Phase A: Participants received 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.	Part 1: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.
Overall Study STARTED	367	357	1422	1402
Overall Study Received at Least 1 Dose of Study Drug	367	357	1422	1402
Overall Study COMPLETED	337	320	1314	1295
Overall Study NOT COMPLETED	30	37	108	107

Reasons for withdrawal

Measure	Part 1: mRNA-1273.529 Phase A: Participants received 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.	Part 1: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and to receive an additional booster outside of the study.
Overall Study Participant Relocation	0	1	2	2
Overall Study Withdrawal by Subject	9	17	40	35
Overall Study Physician Decision	1	0	0	0
Overall Study Lost to Follow-up	16	16	57	60
Overall Study Adverse Event	2	2	2	2
Overall Study COVID-19 Non-Infection Related	0	0	0	1
Overall Study Protocol Violation	2	0	5	3
Overall Study Death	0	1	2	4

Baseline Characteristics

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19

Baseline characteristics by cohort

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.	Total n=3548 Participants Total of all reporting groups
Age, Customized >=16 and <65 Years	241 participants n=5 Participants	235 participants n=7 Participants	945 participants n=5 Participants	935 participants n=4 Participants	2356 participants n=21 Participants
Age, Customized >=65 Years	126 participants n=5 Participants	122 participants n=7 Participants	477 participants n=5 Participants	467 participants n=4 Participants	1192 participants n=21 Participants
Sex: Female, Male Female	200 Participants n=5 Participants	202 Participants n=7 Participants	695 Participants n=5 Participants	694 Participants n=4 Participants	1791 Participants n=21 Participants
Sex: Female, Male Male	167 Participants n=5 Participants	155 Participants n=7 Participants	727 Participants n=5 Participants	708 Participants n=4 Participants	1757 Participants n=21 Participants
Race/Ethnicity, Customized White	353 participants n=5 Participants	335 participants n=7 Participants	1347 participants n=5 Participants	1313 participants n=4 Participants	3348 participants n=21 Participants
Race/Ethnicity, Customized Mixed or Multiple Ethnic Groups	3 participants n=5 Participants	5 participants n=7 Participants	21 participants n=5 Participants	27 participants n=4 Participants	56 participants n=21 Participants
Race/Ethnicity, Customized Asian or Asian British	10 participants n=5 Participants	10 participants n=7 Participants	31 participants n=5 Participants	41 participants n=4 Participants	92 participants n=21 Participants
Race/Ethnicity, Customized Black, African, Caribbean, or Black British	0 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	12 participants n=21 Participants
Race/Ethnicity, Customized Other Ethnic Group	1 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants	17 participants n=21 Participants
Race/Ethnicity, Customized Not Reported	0 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants	7 participants n=4 Participants	20 participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 29 (post vaccination)

Population: Per-Protocol Set for Immunogenicity-SARS-CoV-2 negative (PPSI-Neg) included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed: those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as absorbance units/millilitre (AU/mL). The GMC 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=274 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=277 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 1: Geometric Mean Concentration (GMC) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29	537.7 AU/mL 95% Confidence Interval 478.2 • Interval 478.2 to 604.6	302.8 AU/mL 95% Confidence Interval 274.8 • Interval 274.8 to 333.6	—	—

PRIMARY outcome

Timeframe: Day 85 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=234 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=226 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 85	284.7 AU/mL 95% Confidence Interval 248.0 • Interval 248.0 to 326.7	152.6 AU/mL 95% Confidence Interval 135.1 • Interval 135.1 to 172.3	—	—

PRIMARY outcome

Timeframe: Day 29 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=968 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=894 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 29	465.7 AU/mL 95% Confidence Interval 437.0 • Interval 437.0 to 496.3	311.0 AU/mL 95% Confidence Interval 292.9 • Interval 292.9 to 330.1	—	—

PRIMARY outcome

Timeframe: Day 85 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=761 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=688 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain at Day 85	258.2 AU/mL 95% Confidence Interval 239.3 • Interval 239.3 to 278.7	153.0 AU/mL 95% Confidence Interval 142.2 • Interval 142.2 to 164.6	—	—

PRIMARY outcome

Timeframe: Day 29 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral (prototype) strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=951 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=880 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain at Day 29	2998.8 AU/mL 95% Confidence Interval 2825.4 • Interval 2825.4 to 3182.8	2933.6 AU/mL 95% Confidence Interval 2772.3 • Interval 2772.3 to 3104.4	—	—

PRIMARY outcome

Timeframe: Day 85 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=761 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=685 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against the Ancestral Strain ay Day 85	1753.1 AU/mL 95% Confidence Interval 1650.0 • Interval 1650.0 to 1862.6	1610.2 AU/mL 95% Confidence Interval 1519.6 • Interval 1519.6 to 1706.2	—	—

PRIMARY outcome

Timeframe: Up to Day 8 (7 days post-vaccination)

Population: The Solicited Safety Set included all randomized participants who received the study vaccine and contributed any solicited AR data within the first 7 days after study vaccine administration. Participants were included in the study vaccine arm that they actually received. Here, Overall number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure.

Reactogenicity refers to the occurrence and intensity of selected signs and symptoms (ARs) occurring after vaccine injection. Participants recorded such occurrences in an electronic diary on the day of study vaccine injection and for the 7 days after the day of dosing. Solicited local ARs were injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of the injection. Solicited systemic ARs were headache, fatigue, myalgia (muscle aches all over the body), arthralgia (joint aches in several joints), nausea/vomiting, chills, and fever (oral temperature). The Investigator determined if a solicited AR was also to be recorded as an adverse event (AE). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1421 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1398 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Percentage of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Any Solicited Local ARs	84.5 percentage of participants 95% Confidence Interval 80.4 • Interval 80.4 to 88.0	89.1 percentage of participants 95% Confidence Interval 85.4 • Interval 85.4 to 92.1	83.6 percentage of participants 95% Confidence Interval 81.6 • Interval 81.6 to 85.5	89.9 percentage of participants 95% Confidence Interval 88.2 • Interval 88.2 to 91.4
Parts 1 and 2: Percentage of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Any Solicited Systemic ARs	69.8 percentage of participants 95% Confidence Interval 64.8 • Interval 64.8 to 74.4	74.2 percentage of participants 95% Confidence Interval 69.4 • Interval 69.4 to 78.7	70.2 percentage of participants 95% Confidence Interval 67.7 • Interval 67.7 to 72.5	75.3 percentage of participants 95% Confidence Interval 73.0 • Interval 73.0 to 77.6

PRIMARY outcome

Timeframe: Up to Day 29 (28 days post-vaccination)

Population: The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.

An AE was any untoward medical occurrence associated with the use of a drug/vaccine, whether or not considered related to the drug/vaccine. An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but starts outside the protocol-defined period for reporting solicited ARs (that is, 7 days after vaccination). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Number of Participants With Unsolicited AEs	142 Participants	124 Participants	442 Participants	429 Participants

PRIMARY outcome

Timeframe: Day 1 to end of study (Day 359)

Population: The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.

An AE was considered an SAE if, in the view of either the investigator or Sponsor, it resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Number of Participants With Serious AEs (SAEs)	20 Participants	13 Participants	60 Participants	72 Participants

PRIMARY outcome

Timeframe: Day 1 to end of study (Day 359)

Population: The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.

An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). This would include visits to a clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up, coronavirus disease 2019 [COVID-19]) and visits to HCPs external to the clinic (for example, urgent care, primary care physician). A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Number of Participants With Medically Attended AEs (MAAEs)	242 Participants	257 Participants	956 Participants	964 Participants

PRIMARY outcome

Timeframe: Day 1 to end of study (Day 359)

Population: The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.

An AE leading to withdrawal was defined as any AE that caused the participant to withdraw from the study, regardless of whether the decision to withdraw from the study was made by the participant or by the Investigator. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Number of Participants With AEs Leading to Withdrawal	2 Participants	3 Participants	3 Participants	6 Participants

PRIMARY outcome

Timeframe: Day 1 to end of study (Day 359)

Population: The Safety Set included all randomized participants who received the study vaccine. Participants were included in the study vaccine arm that they actually received.

An AESI is an AE (serious or non serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. Such events may have required further investigation to characterize and understand them. A summary of all Serious and Non Serious AEs, regardless of causality, is located in the 'Adverse Events' section.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=367 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Number of Participants With AEs of Special Interest (AESIs)	42 Participants	28 Participants	60 Participants	60 Participants

SECONDARY outcome

Timeframe: Day 29 and Day 85 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint.

Blood samples for immunogenicity assessments were collected during protocol specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Superiority at Day 29 was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was >1. Superiority at Day 85 was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was >1.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=274 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=277 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 and Day 85 Day 29	537.7 AU/mL Interval 478.2 to 604.6	302.8 AU/mL Interval 274.8 to 333.6	—	—
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 29 and Day 85 Day 85	284.7 AU/mL Interval 248.0 to 326.7	152.6 AU/mL Interval 135.1 to 172.3	—	—

SECONDARY outcome

Timeframe: Day 179 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Number of Participants Analysed signifies those participants who were evaluable for this Outcome Measure.

Blood samples for immunogenicity assessments were collected during protocol specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=160 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=138 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain at Day 179	144.3 AU/mL 95% Confidence Interval 119.4 • Interval 119.4 to 174.5	70.1 AU/mL 95% Confidence Interval 59.0 • Interval 59.0 to 83.4	—	—

SECONDARY outcome

Timeframe: Day 29, Day 85, Day 179 (post vaccination)

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. The ancestral strain was Wuhan-Hu-1. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=270 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=272 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the Ancestral Strain at Day 29, Day 85, and Day 179 Day 29	2699.7 AU/mL Interval 2431.3 to 2997.7	3020.6 AU/mL Interval 2776.5 to 3286.2	—	—
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the Ancestral Strain at Day 29, Day 85, and Day 179 Day 85	1401.2 AU/mL Interval 1236.9 to 1587.4	1559.4 AU/mL Interval 1401.2 to 1735.5	—	—
Part 1: GMC of mRNA-1273.529 and mRNA-1273 Against the Ancestral Strain at Day 29, Day 85, and Day 179 Day 179	734.6 AU/mL Interval 621.8 to 867.9	747.6 AU/mL Interval 644.1 to 867.7	—	—

SECONDARY outcome

Timeframe: Days 29, 85, 179, and 359

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint.

Seroresponse was defined by an increase of the GMC from pre-study vaccination (booster) below the lower limit of quantitation (LLOQ) to at least 4×LLOQ, or a 4-fold or greater rise if pre-study vaccination was ≥LLOQ. The number of participants analysed from the PPSI-Neg population include those with non-missing data at Baseline and the corresponding timepoint. 95% CI calculated using the Clopper-Pearson method.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=274 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=277 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=968 Participants Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=894 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 29 - B.1.1.529 Strain	83.2 percentage of participants Interval 78.2 to 87.4	55.2 percentage of participants Interval 49.2 to 61.2	84.7 percentage of participants Interval 82.3 to 86.9	70.4 percentage of participants Interval 67.2 to 73.3
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 85 - B.1.1.529 Strain	48.3 percentage of participants Interval 41.7 to 54.9	15.9 percentage of participants Interval 11.4 to 21.4	60.6 percentage of participants Interval 57.0 to 64.1	32.3 percentage of participants Interval 28.8 to 35.9
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 179 - B.1.1.529 Strain	18.1 percentage of participants Interval 12.5 to 25.0	2.9 percentage of participants Interval 0.8 to 7.3	37.5 percentage of participants Interval 33.5 to 41.8	25.8 percentage of participants Interval 22.1 to 29.9
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 359 - B.1.1.529 Strain	36.5 percentage of participants Interval 25.6 to 48.5	26.2 percentage of participants Interval 15.8 to 39.1	32.5 percentage of participants Interval 27.1 to 38.3	25.1 percentage of participants Interval 19.9 to 30.9
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 29 - Ancestral Strain	43.1 percentage of participants Interval 37.1 to 49.2	59.0 percentage of participants Interval 52.9 to 65.0	70.9 percentage of participants Interval 67.9 to 73.8	68.4 percentage of participants Interval 65.2 to 71.5
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 85 - Ancestral Strain	14.3 percentage of participants Interval 10.0 to 19.5	21.8 percentage of participants Interval 16.6 to 27.7	38.8 percentage of participants Interval 35.3 to 42.4	33.4 percentage of participants Interval 29.8 to 37.1
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 179 - Ancestral Strain	2.5 percentage of participants Interval 0.7 to 6.4	6.1 percentage of participants Interval 2.7 to 11.6	25.0 percentage of participants Interval 21.4 to 29.0	23.8 percentage of participants Interval 20.1 to 27.9
Parts 1 and 2: Percentage of Participants With Seroresponse Against SARS-CoV-2 Day 359 - Ancestral Strain	2.7 percentage of participants Interval 0.3 to 9.5	8.2 percentage of participants Interval 2.7 to 18.1	8.9 percentage of participants Interval 5.9 to 12.9	12.6 percentage of participants Interval 8.7 to 17.3

SECONDARY outcome

Timeframe: Days 29 and 85

Population: PPSI-Neg included all randomized participants who received the planned dose of study vaccine, had no major protocol deviations with an impact on critical or key study data, and had no serologic or virologic evidence of SARS-CoV-2 infection at Baseline and up to the analysis visit. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this Outcome Measure. Number Analyzed signifies those participants who were evaluable at specified timepoint.

Blood samples for immunogenicity assessments were collected during protocol-specified study visits. The serum neutralizing antibody levels were measured by pseudovirus neutralization assays. Results are reported as AU/mL. The GMC 95% CI was calculated based on the t-distribution of the log-transformed values then back-transformed to the original scale for presentation. Other variant strains include B.1.1.7 Strain, AY.4 Strain, P.1 Strain.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=968 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=895 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains Day 29 - B.1.1.7 Strain	236533.1 AU/mL Interval 227116.7 to 246340.0	225834.1 AU/mL Interval 216536.7 to 235530.8	—	—
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains Day 85 - B.1.1.7 Strain	133951.9 AU/mL Interval 127594.4 to 140626.1	124778.3 AU/mL Interval 118785.1 to 131073.9	—	—
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains Day 29 - AY.4 Strain	244715.5 AU/mL Interval 234951.9 to 254884.8	236066.3 AU/mL Interval 226310.8 to 246242.3	—	—
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains Day 85 - AY.4 Strain	134119.3 AU/mL Interval 127672.7 to 140891.4	127263.6 AU/mL Interval 121106.4 to 133733.8	—	—
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains Day 29 - P.1 Strain	182396.9 AU/mL Interval 175235.0 to 189850.9	175216.7 AU/mL Interval 168018.0 to 182723.9	—	—
Part 2: GMC of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains Day 85 - P.1 Strain	103438.9 AU/mL Interval 98607.6 to 108506.8	97927.0 AU/mL Interval 93264.0 to 102823.2	—	—

SECONDARY outcome

Timeframe: Day 14 through the end of study (Day 359)

Population: Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data.

Asymptomatic SARS-CoV-2 infection was defined as a positive RT-PCR test on a respiratory sample in the absence of symptoms or a positive serologic test for antinucleocapsid antibody after a negative test at time of enrollment.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=995 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=932 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR)	16.9 percentage of participants	17.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 1 through the end of study (Day 359)

Population: Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data.

Symptomatic SARS-CoV-2 infection was defined 2 ways: protocol-defined COVID-19 and Center for Disease Control (CDC) COVID-19. Protocol-defined COVID-19 required at least 2 of the following systemic symptoms: fever, chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical/radiographical evidence of pneumonia, and at least 1 positive nasopharyngeal swab, nasal swab, or saliva sample (RT-PCR). CDC-defined COVID-19 was based on a positive respiratory sample (RT-PCR) and at least 1 of the following systemic or respiratory symptoms: fever, chills, cough, shortness of breath, and/or difficulty breathing, fatigue, muscle and/or body aches, headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhoea.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=995 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=932 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: Percentage of Participants With Symptomatic SARS-CoV-2 Infection Measured by RT-PCR	50.8 percentage of participants	48.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 14 through the end of study (Day 359)

Population: Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data.

The primary case definition of COVID-19 (protocol-defined COVID-19) required the participant to have experienced at least 2 of the following systemic symptoms: fever, chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or the participant must have experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia, and must have at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by RT-PCR.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=995 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=932 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: Percentage of Participants With Primary Case Definition of COVID-19	30.5 percentage of participants	29.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 14 through the end of study (Day 359)

Population: Per-Protocol Set for Efficacy included all participants with a pre-vaccination/Baseline SARS-CoV-2 negative status who received the planned dose of study vaccination and had no major protocol deviations that had an impact on key or critical data.

The secondary case definition of COVID-19 (CDC case definition) was based on a positive RT-PCR test on a respiratory sample and at least 1 of the following systemic or respiratory symptoms: fever, chills, cough, shortness of breath, and/or difficulty breathing, fatigue, muscle and/or body aches (not related to exercise), headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhoea.

Outcome measures

Measure	Part 1: mRNA-1273.529 n=995 Participants Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=932 Participants Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Part 2: Percentage of Participants With Secondary Case Definition of COVID-19	33.5 percentage of participants	30.9 percentage of participants	—	—

Adverse Events

Part 1: mRNA-1273.529

Serious events: 20 serious events

Other events: 68 other events

Deaths: 0 deaths

Part 1: mRNA-1273

Serious events: 13 serious events

Other events: 70 other events

Deaths: 1 deaths

Part 2: mRNA-1273.214

Serious events: 60 serious events

Other events: 207 other events

Deaths: 2 deaths

Part 2: mRNA-1273

Serious events: 72 serious events

Other events: 198 other events

Deaths: 4 deaths

Serious adverse events

Measure	Part 1: mRNA-1273.529 n=367 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Nervous system disorders Intracranial hypotension	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Ischaemic stroke	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Seizure	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Transient ischaemic attack	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Acute coronary syndrome	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Angina pectoris	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Atrial flutter	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Coronary artery stenosis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Extrasystoles	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Sinus tachycardia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Congenital, familial and genetic disorders Corneal dystrophy	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Congenital, familial and genetic disorders Right aortic arch	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Cataract	0.27% 1/367 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Retinal tear	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Uveitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Colitis	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Hiatus hernia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Inguinal hernia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 5 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Richter's hernia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Non-cardiac chest pain	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Pyrexia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Sudden unexplained death in epilepsy	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Jaundice	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Portal vein thrombosis	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Food allergy	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Diverticulitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Herpes zoster	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Nail infection	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pilonidal cyst	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pyelonephritis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.21% 3/1422 • Number of events 3 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Sepsis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Systemic viral infection	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Urinary tract infection	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Limb injury	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Subdural haematoma	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Wrist fracture	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Obesity	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) High-grade B- cell lymphoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1422 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Ageusia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Anosmia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebral haemorrhage	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebral infarction	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebrovascular accident	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Epilepsy	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Anxiety	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Completed suicide	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Acute kidney injury	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Urinary retention	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1422 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.29% 4/1402 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic stenosis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Thrombophlebitis superficial	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Aortic valve stenosis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Arrhythmia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Atrial fibrillation	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.21% 3/1422 • Number of events 3 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Myocardial infarction	0.54% 2/367 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Tachycardia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Cardiac disorders Ventricular tachycardia	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Congenital, familial and genetic disorders Bicuspid aortic valve	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Vertigo	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal pain	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Anal fistula	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Pancreatitis chronic	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Umbilical hernia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Incarcerated hernia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Liver injury	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Anal abscess	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Appendicitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations COVID-19	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Cellulitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gastroenteritis viral	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Lower respiratory tract infection	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Mastoiditis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Otitis externa	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Periorbital cellulitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.56% 2/357 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1422 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Wound infection staphylococcal	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Open fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Dehydration	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Gout	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 2/1402 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumor	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant glioma	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.21% 3/1422 • Number of events 3 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cauda equina syndrome	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Haemorrhagic stroke	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Motor neurone disease	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Myasthenia gravis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Oromandibular dystonia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Parkinson's disease	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Syncope	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Depression	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Suicide attempt	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Pelvi-ureteric obstruction	0.27% 1/367 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Ureterolithiasis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Prostatitis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Skin and subcutaneous tissue disorders Idiopathic angioedema	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic aneurysm	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Deep vein thrombosis	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1422 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1402 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Poor peripheral circulation	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Retinal detachment	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 1/1422 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/1402 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.

Other adverse events

Measure	Part 1: mRNA-1273.529 n=367 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 1: mRNA-1273 n=357 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants were allowed to choose to unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273.214 n=1422 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded to receive an additional booster outside of the study.	Part 2: mRNA-1273 n=1402 participants at risk Phase A: Participants received 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants were allowed to choose to be unblinded and receive an additional booster outside of the study.
Gastrointestinal disorders Diarrhoea	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.4% 5/357 • Number of events 6 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 16/1422 • Number of events 17 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.86% 12/1402 • Number of events 12 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Nausea	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 4/357 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.35% 5/1422 • Number of events 5 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.29% 4/1402 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Fatigue	1.1% 4/367 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 4/357 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.3% 19/1422 • Number of events 19 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.71% 10/1402 • Number of events 10 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Seasonal allergy	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.84% 3/357 • Number of events 3 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.77% 11/1422 • Number of events 11 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.4% 19/1402 • Number of events 20 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Asymptomatic COVID-19	0.54% 2/367 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 4/357 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.84% 12/1422 • Number of events 12 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.57% 8/1402 • Number of events 8 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations COVID-19	7.6% 28/367 • Number of events 28 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	8.4% 30/357 • Number of events 30 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	4.2% 60/1422 • Number of events 60 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	3.6% 51/1402 • Number of events 51 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Nasopharyngitis	0.82% 3/367 • Number of events 3 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.56% 2/357 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.8% 26/1422 • Number of events 26 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.4% 19/1402 • Number of events 19 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Upper respiratory tract infection	4.1% 15/367 • Number of events 15 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.5% 9/357 • Number of events 10 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.35% 5/1422 • Number of events 5 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.86% 12/1402 • Number of events 12 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Arthralgia	0.54% 2/367 • Number of events 2 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 4/357 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.56% 8/1422 • Number of events 8 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.93% 13/1402 • Number of events 14 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Headache	1.6% 6/367 • Number of events 6 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.5% 9/357 • Number of events 12 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.8% 40/1422 • Number of events 43 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.1% 29/1402 • Number of events 29 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Asthma	1.1% 4/367 • Number of events 5 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 1/357 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 4/1422 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.50% 7/1402 • Number of events 7 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Cough	0.82% 3/367 • Number of events 3 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 4/357 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.91% 13/1422 • Number of events 13 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.93% 13/1402 • Number of events 13 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/367 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.1% 4/357 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.35% 5/1422 • Number of events 5 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.29% 4/1402 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.6% 6/367 • Number of events 6 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/357 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.28% 4/1422 • Number of events 4 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.43% 6/1402 • Number of events 6 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.27% 1/367 • Number of events 1 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.4% 5/357 • Number of events 5 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.5% 22/1422 • Number of events 23 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.7% 24/1402 • Number of events 26 • Day 1 to end of study (Day 359) The Safety Set included all randomized participants who received the study vaccine. Note, not all solicited ARs were considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.

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