Trial Outcomes & Findings for A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age (NCT NCT05330975)

Last Updated: 2025-12-30

Results Overview

Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3317 participants

Primary outcome timeframe

Within 7 days after Day 1 injection

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Part A: mRNA-1345 + Placebo Participants received a single injection each of mRNA-1345 and placebo, administered intramuscularly (IM) on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Primary STARTED	249	690	692	560	564	562	0
Primary Received at Least 1 Dose of Any Study Injection	249	685	689	556	562	558	0
Primary Part B Day 1 Injection	0	0	0	556	562	558	0
Primary Part B Day 29 Injection	0	0	0	530	535	536	0
Primary Safety Set	249	685	689	554	562	560	0
Primary Solicited Safety Set (Day 1 Injection)	249	678	683	553	562	557	0
Primary Part B Solicited Safety Set Day 29 Injection	0	0	0	522	532	528	0
Primary Per-protocol (PP) Set	232	639	626	513	514	519	0
Primary COMPLETED	233	652	643	500	516	510	0
Primary NOT COMPLETED	16	38	49	60	48	52	0
Revaccination STARTED	0	0	0	0	0	0	543
Revaccination Part C Safety Set	0	0	0	0	0	0	543
Revaccination Part C Solicited Safety Set	0	0	0	0	0	0	543
Revaccination Part C PP Set	0	0	0	0	0	0	525
Revaccination COMPLETED	0	0	0	0	0	0	525
Revaccination NOT COMPLETED	0	0	0	0	0	0	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: mRNA-1345 + Placebo Participants received a single injection each of mRNA-1345 and placebo, administered intramuscularly (IM) on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Primary Death	0	3	1	1	0	0	0
Primary Other Than Specified	0	1	2	1	2	2	0
Primary Adverse Event	0	0	0	1	0	0	0
Primary Physician Decision	0	0	0	0	1	0	0
Revaccination Adverse Event	0	0	0	0	0	0	3
Revaccination Lost to Follow-up	0	0	0	0	0	0	10
Primary Lost to Follow-up	12	21	38	30	25	28	0
Primary Withdrawal by Subject	4	11	8	23	20	19	0
Primary Protocol Violation	0	2	0	4	0	3	0
Revaccination Withdrawal by Subject	0	0	0	0	0	0	2
Revaccination Death	0	0	0	0	0	0	3

Baseline Characteristics

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: mRNA-1345 + Placebo n=249 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=690 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=692 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 n=560 Participants Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo n=564 Participants Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo n=562 Participants Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Total n=3317 Participants Total of all reporting groups
Age, Customized ≥50 years of age	249 years n=174 Participants	690 years n=166 Participants	692 years n=167 Participants	560 years n=164 Participants	564 years n=671 Participants	562 years n=77 Participants	3317 years n=4 Participants
Sex: Female, Male Female	141 Participants n=174 Participants	367 Participants n=166 Participants	375 Participants n=167 Participants	315 Participants n=164 Participants	317 Participants n=671 Participants	296 Participants n=77 Participants	1811 Participants n=4 Participants
Sex: Female, Male Male	108 Participants n=174 Participants	323 Participants n=166 Participants	317 Participants n=167 Participants	245 Participants n=164 Participants	247 Participants n=671 Participants	266 Participants n=77 Participants	1506 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	91 Participants n=174 Participants	240 Participants n=166 Participants	249 Participants n=167 Participants	213 Participants n=164 Participants	214 Participants n=671 Participants	223 Participants n=77 Participants	1230 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=174 Participants	445 Participants n=166 Participants	442 Participants n=167 Participants	342 Participants n=164 Participants	349 Participants n=671 Participants	333 Participants n=77 Participants	2069 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	5 Participants n=166 Participants	1 Participants n=167 Participants	5 Participants n=164 Participants	1 Participants n=671 Participants	6 Participants n=77 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	189 Participants n=174 Participants	524 Participants n=166 Participants	514 Participants n=167 Participants	430 Participants n=164 Participants	428 Participants n=671 Participants	438 Participants n=77 Participants	2523 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	59 Participants n=174 Participants	157 Participants n=166 Participants	166 Participants n=167 Participants	112 Participants n=164 Participants	113 Participants n=671 Participants	111 Participants n=77 Participants	718 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=174 Participants	4 Participants n=166 Participants	3 Participants n=167 Participants	6 Participants n=164 Participants	8 Participants n=671 Participants	1 Participants n=77 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=174 Participants	1 Participants n=166 Participants	4 Participants n=167 Participants	6 Participants n=164 Participants	4 Participants n=671 Participants	2 Participants n=77 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	1 Participants n=166 Participants	3 Participants n=167 Participants	1 Participants n=164 Participants	3 Participants n=671 Participants	0 Participants n=77 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=174 Participants	1 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=164 Participants	0 Participants n=671 Participants	3 Participants n=77 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · Multiple	0 Participants n=174 Participants	2 Participants n=166 Participants	0 Participants n=167 Participants	1 Participants n=164 Participants	0 Participants n=671 Participants	3 Participants n=77 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	1 Participants n=167 Participants	3 Participants n=164 Participants	8 Participants n=671 Participants	4 Participants n=77 Participants	16 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 7 days after Day 1 injection

Population: Solicited Safety Set included all randomized participants who received any study intervention and contributed any solicited ARs data from the time of study injection on Day 1 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=249 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=678 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=683 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection	147 Participants	395 Participants	291 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 28 (28 days after Day 1 injection)

Population: The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=249 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=685 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=689 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Number of Participants With Unsolicited Adverse Events (AEs) After Day 1 Injection	21 Participants	57 Participants	46 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 181 (end of Study Part A)

A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) 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 are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=249 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=685 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=689 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal AESI	0 Participants	1 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal AEs Leading to Withdrawal	0 Participants	3 Participants	1 Participants	—	—	—	—
Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal MAAE	41 Participants	136 Participants	114 Participants	—	—	—	—
Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal SAE	4 Participants	28 Participants	24 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 29

Population: PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and had no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=232 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=639 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) Neutralizing Antibodies (NAbs) at Day 29	17271.72 IU/mL Interval 14448.78 to 20646.2	13929.98 IU/mL Interval 12291.04 to 15787.47	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 29

Seroresponse was defined as ≥4 × lower limit of quantification (LLOQ) if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=232 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=639 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Percentage of Participants With Seroresponse in RSV-A NAbs at Day 29	72.4 percentage of participants Interval 66.2 to 78.1	61.2 percentage of participants Interval 57.3 to 65.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 29

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=630 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=619 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29 Influenza A H3N2 Antibody	144.14 titer Interval 130.37 to 159.36	148.69 titer Interval 134.35 to 164.55	—	—	—	—	—
Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29 Influenza A H1N1 Antibody	271.27 titer Interval 239.71 to 306.99	303.92 titer Interval 268.24 to 344.35	—	—	—	—	—
Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29 Influenza B Washington Antibody	57.59 titer Interval 52.01 to 63.77	62.13 titer Interval 56.05 to 68.86	—	—	—	—	—
Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29 Influenza B Phuket Antibody	38.52 titer Interval 34.91 to 42.5	42.40 titer Interval 38.39 to 46.82	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after Day 1 injection

Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=553 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=557 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=556 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 1 Injection	358 Participants	394 Participants	361 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after Day 29 injection

Population: Part B Solicited Safety Set Day 29 Injection consisted of all randomized participants who received any study injection on Day 29 and contributed any solicited ARs. Participants were included in the treatment arm corresponding to the study drug they actually received. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=522 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=532 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=528 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 29 Injection	265 Participants	147 Participants	148 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 28 (28 days after Day 1 injection)

Population: Safety Set Day 1 injection included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or PT/PTT) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=554 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=562 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=560 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Number of Participants With Unsolicited AEs After Day 1 Injection	41 Participants	54 Participants	44 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 29 through Day 57 (28 days after Day 29 injection)

Population: Safety Set Day 29 injection included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=530 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=535 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=536 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Number of Participants With Unsolicited AEs After Day 29 Injection	31 Participants	25 Participants	26 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 through Day 211

Population: Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=554 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=562 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=560 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal MAAEs	109 Participants	107 Participants	97 Participants	—	—	—	—
Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal SAEs	18 Participants	13 Participants	10 Participants	—	—	—	—
Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal AESIs	5 Participants	2 Participants	7 Participants	—	—	—	—
Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal AEs Leading to Withdrawal	1 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 29

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=508 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=506 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMT of Serum RSV-A at Day 29	19071.03 IU/mL Interval 17130.14 to 21231.84	15171.23 IU/mL Interval 13626.94 to 16890.53	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline to Day 29

Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=508 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=506 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse for RSV-A Neutralizing Abs From Baseline to Day 29	75.4 percentage of participants Interval 71.4 to 79.1	70.9 percentage of participants Interval 66.8 to 74.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 29

The model-based GM titer was estimated on ANCOVA model. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 arbitrary units (AU)/milliliters (mL) and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529. As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=513 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=519 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29 Wuhan-Hu-1	9881.69 AU/mL Interval 9097.35 to 10733.66	10300.49 AU/mL Interval 9490.13 to 11180.04	—	—	—	—	—
Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29 B.1.1.529	2353.15 AU/mL Interval 2115.26 to 2617.8	2342.87 AU/mL Interval 2107.26 to 2604.82	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline to Day 29

Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. mRNA-As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=513 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=519 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 29 Wuhan-Hu-1	52.7 percentage of participants Interval 48.2 to 57.1	52.5 percentage of participants Interval 48.1 to 56.9	—	—	—	—	—
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 29 B.1.1.529	68.4 percentage of participants Interval 64.2 to 72.4	69.4 percentage of participants Interval 65.2 to 73.3	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after Day 1 revaccination

Population: Solicited Safety Set included all participants who received revaccination with mRNA-1345 and contributed any solicited AR data. Participants were included in the treatment arm corresponding to the study drug they actually received.

Solicited ARs were collected in an electronic eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=543 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Number of Participants With Solicited Local and Systemic Within 7 Days After Revaccination Day 1	338 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Revaccination Day 1 through Day 28 (28 days after revaccination Day 1)

Population: Safety Set included all participants who received any revaccination with mRNA-1345. Participants were included in the treatment arm corresponding to the study drug they actually received.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or PT/PTT) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=543 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Number of Participants With Unsolicited AEs Within 28 Days After Revaccination Day 1	31 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Revaccination Day 1 through Day 181

Population: Safety Set included all participants who received any revaccination with mRNA-1345. Participants were included in the treatment arm corresponding to the study drug they actually received.

A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=543 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Number of Participants With MAAEs	105 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Revaccination Day 1 through Day 361

Population: Safety Set included all participants who received any revaccination with mRNA-1345. Participants were included in the treatment arm corresponding to the study drug they actually received.

An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. An AESI is an AE (serious or nonserious) 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 are required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=543 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal SAEs	28 Participants	—	—	—	—	—	—
Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal AESIs	2 Participants	—	—	—	—	—	—
Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal AEs Leading to Withdrawal	5 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Primary Vaccination Day 29 to Revaccination Day 29

Population: PP Set: participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B. mRNA-1345 Revaccination Day 29 and mRNA-1345 primary vaccination Day 29 (received in Part B) are presented.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=524 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=525 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: GMT of Serum RSV-A and RSV-B NAbs mRNA-1345 Revaccination Day 29 Compared to Primary Vaccination Day 29 RSV-A	18190.30 IU/mL Interval 16467.13 to 20093.79	19649.18 IU/mL Interval 18017.92 to 21428.12	—	—	—	—	—
Part C: GMT of Serum RSV-A and RSV-B NAbs mRNA-1345 Revaccination Day 29 Compared to Primary Vaccination Day 29 RSV-B	6746.41 IU/mL Interval 6136.32 to 7417.16	6123.47 IU/mL Interval 5599.77 to 6696.14	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=232 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=639 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: GMT of Serum RSV-B NAbs at Day 29	10436.03 IU/mL Interval 8973.29 to 12137.2	8909.80 IU/mL Interval 8016.02 to 9903.24	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=232 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=639 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Percentage of Participants With Seroresponse in RSV-B NAbs at Day 29	63.8 percentage of participants Interval 57.2 to 70.0	49.5 percentage of participants Interval 45.5 to 53.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Population: PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Seroconversion was defined as a titer ≥1:40 if baseline was \<1:10 or a 4-fold or greater rise from baseline in the titers if Baseline was ≥1:10. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=609 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=595 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181 Influenza B Washington Antibody	19.5 percentage of participants Interval 16.5 to 22.9	19.7 percentage of participants Interval 16.5 to 23.1	—	—	—	—	—
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181 Influenza B Phuket Antibody	17.2 percentage of participants Interval 14.3 to 20.5	18.8 percentage of participants Interval 15.8 to 22.2	—	—	—	—	—
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181 Influenza A H1N1 Antibody	41.1 percentage of participants Interval 37.1 to 45.1	38.8 percentage of participants Interval 34.9 to 42.9	—	—	—	—	—
Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181 Influenza A H3N2 Antibody	29.4 percentage of participants Interval 25.8 to 33.2	28.7 percentage of participants Interval 25.1 to 32.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Population: PP Set: All participants who received the assigned study injections according to protocol, complied with immunogenicity sampling (baseline and at least 1 Day 29 post-injection assessment), and have no major protocol deviations affecting the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed' = participants evaluable for specified category.

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=218 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=613 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: GMT of Serum RSV-A and RSV-B NAbs at Day 181 RSV-A	7551.13 IU/mL Interval 6504.13 to 8766.68	6429.48 IU/mL Interval 5850.16 to 7066.17	—	—	—	—	—
Part A: GMT of Serum RSV-A and RSV-B NAbs at Day 181 RSV-B	2402.86 IU/mL Interval 2120.18 to 2723.23	2301.47 IU/mL Interval 2114.95 to 2504.44	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=218 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=613 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Geometric Mean Fold Rise (GMFR) of Serum RSV-A and RSV-B NAbs at Day 181 RSV-A	3.46 ratio Interval 2.97 to 4.04	2.19 ratio Interval 1.99 to 2.4	—	—	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of Serum RSV-A and RSV-B NAbs at Day 181 RSV-B	1.32 ratio Interval 1.17 to 1.49	0.94 ratio Interval 0.87 to 1.02	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ.As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=218 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=613 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181 RSV-B	13.3 percentage of participants Interval 9.1 to 18.5	6.7 percentage of participants Interval 4.8 to 9.0	—	—	—	—	—
Part A: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181 RSV-A	46.8 percentage of participants Interval 40.0 to 53.6	29.9 percentage of participants Interval 26.3 to 33.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Day 181

≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=218 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=613 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181 RSV-A	67.0 percentage of participants Interval 60.3 to 73.2	54.1 percentage of participants Interval 50.0 to 58.1	—	—	—	—	—
Part A: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181 RSV-B	32.1 percentage of participants Interval 26.0 to 38.7	21.0 percentage of participants Interval 17.9 to 24.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=613 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=601 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza A H1N1 Antibody	155.59 titer Interval 138.1 to 175.31	156.47 titer Interval 139.65 to 175.33	—	—	—	—	—
Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza A H3N2 Antibody	113.58 titer Interval 101.54 to 127.06	109.36 titer Interval 98.28 to 121.68	—	—	—	—	—
Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza B Washington Antibody	32.11 titer Interval 29.1 to 35.43	35.03 titer Interval 31.76 to 38.64	—	—	—	—	—
Part A: GMT of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza B Phuket Antibody	25.64 titer Interval 23.34 to 28.17	26.43 titer Interval 24.17 to 28.91	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. 95% CI for GMFR (postinjection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=609 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=595 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza A H1N1 Antibody	3.21 ratio Interval 2.8 to 3.68	3.08 ratio Interval 2.7 to 3.51	—	—	—	—	—
Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza A H3N2 Antibody	2.28 ratio Interval 2.04 to 2.55	2.23 ratio Interval 2.0 to 2.49	—	—	—	—	—
Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza B Washington Antibody	1.80 ratio Interval 1.66 to 1.96	1.95 ratio Interval 1.79 to 2.13	—	—	—	—	—
Part A: GMFR of Serum Anti-HA Ab Level, as Measured by HAI Assay for Influenza at Day 181 Influenza B Phuket Antibody	1.76 ratio Interval 1.63 to 1.9	1.79 ratio Interval 1.66 to 1.93	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=511 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=513 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMT of Serum RSV-B NAbs at Day 29	6584.54 IU/mL Interval 5961.73 to 7272.4	5843.94 IU/mL Interval 5292.14 to 6453.28	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Day 29

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=511 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=513 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse in RSV-B NAbs From Baseline to Day 29	51.9 percentage of participants Interval 47.4 to 56.3	46.0 percentage of participants Interval 41.6 to 50.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 181 RSV-A	6456.32 IU/mL Interval 5830.84 to 7148.91	5221.87 IU/mL Interval 4723.14 to 5773.26	—	—	—	—	—
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 181 RSV-B	2447.67 IU/mL Interval 2236.91 to 2678.28	2274.83 IU/mL Interval 2070.95 to 2498.79	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 181 RSV-B	1.61 ratio Interval 1.48 to 1.75	1.49 ratio Interval 1.38 to 1.61	—	—	—	—	—
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 181 RSV-A	2.91 ratio Interval 2.65 to 3.2	2.58 ratio Interval 2.36 to 2.82	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

95% CI for GM value was calculated based on the t-distribution of the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 AU/mL and ULOQ was 24503 for B1.1.529.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=485 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=486 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181 Wuhan-Hu-1	4075.34 AU/mL Interval 3722.53 to 4461.58	3615.45 AU/mL Interval 3272.04 to 3994.91	3665.39 AU/mL Interval 3335.37 to 4028.07	—	—	—	—
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181 B.1.1.529	1002.35 AU/mL Interval 894.17 to 1123.61	889.75 AU/mL Interval 791.84 to 999.76	919.49 AU/mL Interval 820.46 to 1030.46	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=485 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=486 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181 Wuhan-Hu-1	2.12 ratio Interval 1.9 to 2.38	1.94 ratio Interval 1.72 to 2.19	1.84 ratio Interval 1.65 to 2.06	—	—	—	—
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 181 B.1.1.529	3.57 ratio Interval 3.12 to 4.09	3.27 ratio Interval 2.83 to 3.78	3.13 ratio Interval 2.75 to 3.55	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Day 181

Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 111433 for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=485 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=486 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 181 Wuhan-Hu-1	24.1 percentage of participants Interval 20.3 to 28.2	23.6 percentage of participants Interval 19.9 to 27.7	19.8 percentage of participants Interval 16.4 to 23.7	—	—	—	—
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 181 B.1.1.529	44.7 percentage of participants Interval 40.2 to 49.3	41.0 percentage of participants Interval 36.6 to 45.6	40.5 percentage of participants Interval 36.1 to 45.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 181

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181 RSV-A	34.9 percentage of participants Interval 30.6 to 39.3	30.2 percentage of participants Interval 26.1 to 34.5	—	—	—	—	—
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 181 RSV-B	14.9 percentage of participants Interval 11.9 to 18.5	12.7 percentage of participants Interval 9.9 to 16.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Day 181

≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=476 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181 RSV-A	62.8 percentage of participants Interval 58.3 to 67.2	58.3 percentage of participants Interval 53.8 to 62.7	—	—	—	—	—
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 181 RSV-B	36.4 percentage of participants Interval 32.1 to 40.9	35.7 percentage of participants Interval 31.5 to 40.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=474 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 211 RSV-A	5921.09 IU/mL Interval 5357.33 to 6544.17	4696.74 IU/mL Interval 4245.92 to 5195.44	—	—	—	—	—
Part B: GMT of Serum RSV-A and RSV-B NAbs at Day 211 RSV-B	2261.26 IU/mL Interval 2069.7 to 2470.56	2132.70 IU/mL Interval 1943.36 to 2340.49	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=474 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 211 RSV-A	2.71 ratio Interval 2.48 to 2.98	2.35 ratio Interval 2.15 to 2.56	—	—	—	—	—
Part B: GMFR of Serum RSV-A and RSV-B NAbs at Day 211 RSV-B	1.50 ratio Interval 1.39 to 1.63	1.40 ratio Interval 1.3 to 1.51	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=471 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=485 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=486 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211 Wuhan-Hu-1	3551.74 AU/mL Interval 3245.1 to 3887.35	3034.11 AU/mL Interval 2743.48 to 3355.54	3123.69 AU/mL Interval 2841.55 to 3433.84	—	—	—	—
Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211 B.1.1.529	923.10 AU/mL Interval 826.89 to 1030.51	797.17 AU/mL Interval 708.18 to 897.33	795.90 AU/mL Interval 709.19 to 893.21	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=471 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=485 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=486 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211 B.1.1.529	3.31 ratio Interval 2.9 to 3.79	2.95 ratio Interval 2.56 to 3.4	2.72 ratio Interval 2.39 to 3.1	—	—	—	—
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 211 Wuhan-Hu-1	1.87 ratio Interval 1.66 to 2.09	1.64 ratio Interval 1.45 to 1.85	1.59 ratio Interval 1.42 to 1.77	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=471 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=485 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=486 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs at Day 211 Wuhan-Hu-1	21.1 percentage of participants Interval 17.5 to 25.1	20.3 percentage of participants Interval 16.7 to 24.1	17.8 percentage of participants Interval 14.5 to 21.5	—	—	—	—
Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs at Day 211 B.1.1.529	41.4 percentage of participants Interval 36.9 to 46.0	38.8 percentage of participants Interval 34.4 to 43.3	37.0 percentage of participants Interval 32.7 to 41.5	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=474 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 211 RSV-A	32.5 percentage of participants Interval 28.3 to 36.9	26.5 percentage of participants Interval 22.7 to 30.7	—	—	—	—	—
Part B: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAb Titers at Day 211 RSV-B	12.3 percentage of participants Interval 9.5 to 15.6	10.1 percentage of participants Interval 7.5 to 13.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 211

≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=474 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=487 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 211 RSV-A	57.8 percentage of participants Interval 53.2 to 62.3	53.7 percentage of participants Interval 49.2 to 58.2	—	—	—	—	—
Part B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A and RSV-B NAb Titers at Day 211 RSV-B	33.7 percentage of participants Interval 29.4 to 38.1	30.6 percentage of participants Interval 26.5 to 34.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Before Primary Vaccination in Part B) to Revaccination Day 29

Population: PP Set: All participants received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.

Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. Primary vaccination Day 29 (received in Part B) and Revaccination Day 29 are presented.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=523 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=524 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs From Baseline (Before Primary Vaccination) to Revaccination Day 29 RSV-A	75.3 percentage of participants Interval 71.3 to 78.9	77.5 percentage of participants Interval 73.7 to 81.0	—	—	—	—	—
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs From Baseline (Before Primary Vaccination) to Revaccination Day 29 RSV-B	48.2 percentage of participants Interval 43.8 to 52.6	47.5 percentage of participants Interval 43.2 to 51.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Revaccination Day 361

Population: PP Set: All participants who received mRNA-1345 revaccination, had prerevaccination and at least 1 postinjection assessment of immunogenicity after revaccination, complied with immunogenicity testing schedule, and had no major protocol derivations. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=497 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: GMT of Serum RSV-A and RSV-B NAbs at Revaccination Day 361 RSV-A	4708.27 IU/mL Interval 4279.78 to 5179.67	—	—	—	—	—	—
Part C: GMT of Serum RSV-A and RSV-B NAbs at Revaccination Day 361 RSV-B	2251.24 IU/mL Interval 2054.09 to 2467.32	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Revaccination Day 361

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=496 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: GMFR of Serum RSV-A and RSV-B NAbs at Revaccination Day 361 RSV-A	2.26 ratio Interval 2.06 to 2.48	—	—	—	—	—	—
Part C: GMFR of Serum RSV-A and RSV-B NAbs at Revaccination Day 361 RSV-B	1.42 ratio Interval 1.31 to 1.53	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Revaccination Day 361

Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=496 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs at Revaccination Day 361 RSV-A	25.8 percentage of participants Interval 22.0 to 29.9	—	—	—	—	—	—
Part C: Percentage of Participants With Seroresponse in RSV-A and RSV-B NAbs at Revaccination Day 361 RSV-B	11.5 percentage of participants Interval 8.8 to 14.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Revaccination Day 361

≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=496 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Part C: Percentage of Participants With ≥2-fold Increases From Baseline (Before Primary Vaccination) in RSV-A and RSV-B NAb Titers at Revaccination Day 361 RSV-B	32.7 percentage of participants Interval 28.5 to 37.0	—	—	—	—	—	—
Part C: Percentage of Participants With ≥2-fold Increases From Baseline (Before Primary Vaccination) in RSV-A and RSV-B NAb Titers at Revaccination Day 361 RSV-A	53.0 percentage of participants Interval 48.5 to 57.5	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C

Population: Randomized Set included all participants who were randomized in the study, regardless of the participant's treatment status in the study.

A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable and/or the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.

Outcome measures

Outcome measures
Measure	Part A: mRNA-1345 + Placebo n=249 Participants Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria® Quadrivalent n=690 Participants Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria® Quadrivalent + Placebo n=692 Participants Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 n=560 Participants Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo n=564 Participants Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo n=562 Participants Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: mRNA-1345 Revaccination n=543 Participants Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Number of Deaths During the Study Deaths	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Deaths During the Study Deaths related to study drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Part A: mRNA-1345 + Placebo

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Part A: mRNA-1345 + Afluria Quadrivalent

Serious events: 28 serious events

Other events: 0 other events

Deaths: 3 deaths

Part A: Afluria Quadrivalent + Placebo

Serious events: 24 serious events

Other events: 0 other events

Deaths: 1 deaths

Part B: mRNA-1345 + Placebo + mRNA-1273.214

Serious events: 18 serious events

Other events: 0 other events

Deaths: 1 deaths

Part B: mRNA-1345 + mRNA-1273.214 + Placebo

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B: mRNA-1273.214 + Placebo + Placebo

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Part C: Revaccination

Serious events: 28 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Part A: mRNA-1345 + Placebo n=249 participants at risk Participants received a single injection each of mRNA-1345 and placebo, administered IM on Day 1.	Part A: mRNA-1345 + Afluria Quadrivalent n=685 participants at risk Participants received a single injection each of mRNA-1345 and Afluria® quadrivalent, administered IM on Day 1.	Part A: Afluria Quadrivalent + Placebo n=689 participants at risk Participants received a single injection each of Afluria® quadrivalent and placebo, administered IM on Day 1.	Part B: mRNA-1345 + Placebo + mRNA-1273.214 n=554 participants at risk Participants received a single injection of mRNA-1345 and placebo, administered IM on Day 1. (Note: An additional injection of mRNA-1273.214 was administered on Day 29 to allow all study participants to receive an mRNA-1273.214 booster vaccination.)	Part B: mRNA-1345 + mRNA-1273.214 + Placebo n=562 participants at risk Participants received a single injection each of mRNA-1345 and mRNA-1273.214, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part B: mRNA-1273.214 + Placebo + Placebo n=560 participants at risk Participants received a single injection each of mRNA-1273.214 and placebo, administered IM on Day 1. (Note: An additional injection of placebo was administered on Day 29 to maintain blinding.)	Part C: Revaccination n=543 participants at risk Participants received mRNA-1345 primary vaccination in Part B and opted to receive revaccination in Part C. Participants received a single mRNA-1345 injection at least 12 months (but not longer than 15 months) after primary vaccination.
Infections and infestations Abscess neck	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Bacterial sepsis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations COVID-19	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations COVID-19 pneumonia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Cellulitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.29% 2/685 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.36% 2/562 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.55% 3/543 • Number of events 3 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Cellulitis staphylococcal	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Escherichia bacteraemia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Escherichia sepsis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Influenza	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Metapneumovirus bronchiolitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Osteomyelitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Pneumonia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.36% 2/554 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.37% 2/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Pneumonia bacterial	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Pneumonia necrotising	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Pneumonia pneumococcal	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Pyelonephritis acute	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Sepsis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.44% 3/685 • Number of events 3 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Septic shock	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.37% 2/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Infections and infestations Urinary tract infection	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer stage III	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Ataxia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the rectum	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.40% 1/249 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Triple negative breast cancer	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Blood and lymphatic system disorders Anaemia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.36% 2/554 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Psychiatric disorders Acute psychosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Psychiatric disorders Delirium tremens	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Psychiatric disorders Intentional self-injury	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Psychiatric disorders Mental status changes	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Psychiatric disorders Suicidal ideation	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Cerebrovascular accident	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Ischaemic stroke	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Neuropathy peripheral	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Presyncope	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Subdural effusion	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Syncope	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Nervous system disorders Transient ischaemic attack	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Ear and labyrinth disorders Vertigo	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.29% 2/689 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Acute coronary syndrome	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Acute left ventricular failure	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Acute myocardial infarction	0.40% 1/249 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Angina pectoris	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.37% 2/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Aortic valve stenosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Atrial fibrillation	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Bradycardia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Cardiac arrest	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Cardiac failure	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Cardiac failure congestive	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Cardiogenic shock	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Coronary artery disease	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Coronary artery occlusion	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Myocardial infarction	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Pericardial effusion	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Cardiac disorders Sinus node dysfunction	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Deep vein thrombosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Hypertension	0.40% 1/249 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Hypertensive crisis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Hypertensive urgency	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.29% 2/689 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Hypotension	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Hypovolaemic shock	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Superficial vein thrombosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Vascular disorders Venous occlusion	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.29% 2/689 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Colitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Diarrhoea	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Necrotising oesophagitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Gastrointestinal disorders Umbilical hernia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Hepatobiliary disorders Cholecystitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Hepatobiliary disorders Portal hypertension	0.40% 1/249 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Skin and subcutaneous tissue disorders Skin ulcer	0.40% 1/249 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.40% 1/249 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Renal and urinary disorders Acute kidney injury	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.37% 2/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
General disorders Death	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/554 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Fall	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.37% 2/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Overdose	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/562 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/560 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.37% 2/543 • Number of events 2 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/685 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/689 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.18% 1/543 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/249 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/685 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.15% 1/689 • Number of events 1 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/554 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/562 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/560 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.	0.00% 0/543 • All-cause mortality and serious adverse events were collected throughout the entire period of the study (up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C). Other (not including serious) adverse events were collected for 28 days after the vaccination unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received the study drug. Adverse event data were collected during the study visit by the investigator. A participant may experience the same event both as SAE and non-SAE.

Other adverse events

Adverse event data not reported

Additional Information

Moderna WeCare Team

ModernaTX, Inc.

Phone: +1-866-663-3762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place