Trial Outcomes & Findings for A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above (NCT NCT06389487)

NCT ID: NCT06389487

Last Updated: 2025-09-25

Results Overview

RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1459 participants
• Primary outcome timeframe: At Day 31
• Results posted on: 2025-09-25

Participant Flow

1459 participants were enrolled, out of which 1458 were included in the Exposed set and started the study.

Participant milestones

Measure	Part A: RSV-A-AIR Group Adult (A) participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group Older adults (OA) participants, greater than or equal to (≥) 60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Overall Study STARTED	426	429	603
Overall Study COMPLETED	414	422	586
Overall Study NOT COMPLETED	12	7	17

Reasons for withdrawal

Measure	Part A: RSV-A-AIR Group Adult (A) participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group Older adults (OA) participants, greater than or equal to (≥) 60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Overall Study Lost to Follow-up	9	5	13
Overall Study Protocol Violation	0	0	2
Overall Study Withdrawal by Subject	2	2	1
Overall Study Other	1	0	1

Baseline Characteristics

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

Baseline characteristics by cohort

Measure	Part A: RSV-A-AIR Group n=426 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=429 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=603 Participants Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.	Total n=1458 Participants Total of all reporting groups
Age, Continuous	38.9 YEARS STANDARD_DEVIATION 7.8 • n=5 Participants	68.6 YEARS STANDARD_DEVIATION 5.7 • n=7 Participants	38.1 YEARS STANDARD_DEVIATION 8.7 • n=5 Participants	47.3 YEARS STANDARD_DEVIATION 15.7 • n=4 Participants
Sex: Female, Male Female	247 Participants n=5 Participants	220 Participants n=7 Participants	347 Participants n=5 Participants	814 Participants n=4 Participants
Sex: Female, Male Male	179 Participants n=5 Participants	209 Participants n=7 Participants	256 Participants n=5 Participants	644 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	8 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Asian	60 Participants n=5 Participants	50 Participants n=7 Participants	64 Participants n=5 Participants	174 Participants n=4 Participants
Race/Ethnicity, Customized Balck or African American	77 Participants n=5 Participants	54 Participants n=7 Participants	181 Participants n=5 Participants	312 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized White	255 Participants n=5 Participants	302 Participants n=7 Participants	274 Participants n=5 Participants	831 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	4 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Multiple Race Categories	19 Participants n=5 Participants	22 Participants n=7 Participants	59 Participants n=5 Participants	100 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the per protocol set (PPS) which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.

RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)

Outcome measures

Measure	Part A: RSV-A-AIR Group n=393 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=417 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)	11910.1 Titer Interval 10927.3 to 12981.4	8593.6 Titer Interval 7904.3 to 9343.0	—

PRIMARY outcome

Timeframe: Day 31 compared with baseline (Day 1)

Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.

SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=342 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=324 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers	87.0 Percentage of participants Interval 83.3 to 90.2	77.7 Percentage of participants Interval 73.4 to 81.6	—

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.

RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=392 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=417 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A: RSV-B Neutralizing Titers Expressed as Group GMTs	12496.4 Titer Interval 11482.4 to 13599.9	9089.7 Titer Interval 8373.7 to 9866.9	—

PRIMARY outcome

Timeframe: Day 31 compared with baseline (Day 1)

Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.

SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=342 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=322 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers	87.2 Percentage of participants Interval 83.5 to 90.4	77.2 Percentage of participants Interval 72.9 to 81.2	—

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 4

Population: Analysis was performed on the Exposed Set, which included all participants who received the study intervention. Analysis per group is based on age and medical condition. Only those participants with solicited administration site events were included in this analysis.

Assessed solicited administration site events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=425 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=428 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=601 Participants Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A and B: Number of Participants Reporting Any Solicited Administration Site Events Pain	358 Participants	246 Participants	422 Participants
Part A and B: Number of Participants Reporting Any Solicited Administration Site Events Redness	36 Participants	23 Participants	52 Participants
Part A and B: Number of Participants Reporting Any Solicited Administration Site Events Swelling	25 Participants	19 Participants	47 Participants

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 4

Population: Exposed Set. Only those participants with solicited systemic events were included in this analysis.

Assessed solicited systemic events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=425 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=428 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=602 Participants Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A and B: Number of Participants Reporting Any Solicited Systemic Events Fever	25 Participants	11 Participants	26 Participants
Part A and B: Number of Participants Reporting Any Solicited Systemic Events Headache	198 Participants	78 Participants	250 Participants
Part A and B: Number of Participants Reporting Any Solicited Systemic Events Myalgia	284 Participants	169 Participants	331 Participants
Part A and B: Number of Participants Reporting Any Solicited Systemic Events Arthralgia	124 Participants	78 Participants	167 Participants
Part A and B: Number of Participants Reporting Any Solicited Systemic Events Fatigue	275 Participants	148 Participants	337 Participants

SECONDARY outcome

Timeframe: Day 1 (post dose) to Day 30

Population: Exposed Set

An unsolicited AE wass an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=426 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=429 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=603 Participants Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs)	72 Participants	76 Participants	118 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Month 6)

Population: Exposed Set

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=426 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=429 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=603 Participants Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs Any SAEs	4 Participants	13 Participants	10 Participants
Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs Related SAEs	0 Participants	0 Participants	0 Participants
Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs Fatal SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Month 6)

Population: Exposed Set

AESIs assessed were potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF). pIMDs were a subset of AESIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF were considered as AESI.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=426 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=429 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=603 Participants Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs)	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: At Day 1 (pre-dose), at Month 1 and Month 6

Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.

RSV-A neutralizing titers are given as GMTs and are expressed as ED60.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=419 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=425 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A: RSV-A Neutralizing Titers Expressed as GMTs Day 1	892.6 Titer Interval 821.5 to 969.9	913.8 Titer Interval 837.2 to 997.4	—
Part A: RSV-A Neutralizing Titers Expressed as GMTs Month 1	11853.4 Titer Interval 10875.3 to 12919.5	8632.4 Titer Interval 7858.3 to 9482.6	—
Part A: RSV-A Neutralizing Titers Expressed as GMTs Month 6	4439.8 Titer Interval 4042.1 to 4876.7	3917.7 Titer Interval 3553.0 to 4319.7	—

SECONDARY outcome

Timeframe: At Day 1 (pre-dose), at Month 1 and Month 6

Population: Analysis was performed on the PPS which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on age and medical condition including participants with data available at specified timepoint.

RSV-B neutralizing titers are given as GMTs and are expressed as ED60.

Outcome measures

Measure	Part A: RSV-A-AIR Group n=418 Participants Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=425 Participants Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Part A: RSV-B Neutralizing Titers Expressed as GMTs Day 1	988.1 Titer Interval 905.9 to 1077.8	1045.1 Titer Interval 953.7 to 1145.2	—
Part A: RSV-B Neutralizing Titers Expressed as GMTs Month 1	12337.6 Titer Interval 11334.3 to 13429.7	9178.5 Titer Interval 8367.7 to 10067.8	—
Part A: RSV-B Neutralizing Titers Expressed as GMTs Month 6	4335.6 Titer Interval 3941.7 to 4769.0	4355.0 Titer Interval 3971.4 to 4775.7	—

Adverse Events

Part A: RSV-A-AIR Group

Serious events: 4 serious events

Other events: 386 other events

Deaths: 0 deaths

Part A: RSV-OA Group

Serious events: 13 serious events

Other events: 310 other events

Deaths: 0 deaths

Part B: RSV-A-AIR Group

Serious events: 10 serious events

Other events: 483 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: RSV-A-AIR Group n=426 participants at risk Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=429 participants at risk Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=603 participants at risk Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Infections and infestations Cellulitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Pneumonia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Sepsis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Gastroenteritis	0.23% 1/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Pulmonary sepsis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Escherichia bacteraemia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Infective exacerbation of asthma	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Osteomyelitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Wound cellulitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Neurological symptom	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Transient global amnesia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Transient ischaemic attack	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Cardiac disorders Atrial fibrillation	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Cardiac disorders Atrioventricular block complete	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Cardiac disorders Acute myocardial infarction	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer stage III	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Pelvic venous thrombosis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Thrombophlebitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Hypertension	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Colitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Alcoholic pancreatitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Angioedema	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Renal and urinary disorders Acute kidney injury	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.

Other adverse events

Measure	Part A: RSV-A-AIR Group n=426 participants at risk Adult participants, 18-49 years of age (YOA), at increased risk (AIR) for respiratory syncytial virus (RSV) disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.	Part A: RSV-OA Group n=429 participants at risk Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.	Part B: RSV-A-AIR Group n=603 participants at risk Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
General disorders Injection site pain	84.0% 358/426 • Number of events 364 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	57.3% 246/429 • Number of events 247 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	70.0% 422/603 • Number of events 425 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Fatigue	64.6% 275/426 • Number of events 284 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	34.5% 148/429 • Number of events 151 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	56.1% 338/603 • Number of events 352 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site erythema	8.7% 37/426 • Number of events 39 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	5.4% 23/429 • Number of events 23 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	8.6% 52/603 • Number of events 53 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site swelling	5.9% 25/426 • Number of events 26 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	4.4% 19/429 • Number of events 19 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	7.8% 47/603 • Number of events 47 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Pyrexia	6.1% 26/426 • Number of events 26 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	2.8% 12/429 • Number of events 12 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	4.8% 29/603 • Number of events 30 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Chills	1.2% 5/426 • Number of events 5 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	2.2% 13/603 • Number of events 13 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site pruritus	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.2% 7/603 • Number of events 7 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Feeling hot	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.50% 3/603 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Malaise	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Pain	0.70% 3/426 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Axillary pain	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site bruising	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Swelling	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site warmth	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Asthenia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site induration	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Oedema peripheral	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Vaccination site erythema	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Feeling of body temperature change	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Influenza like illness	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site macule	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Administration site pruritus	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Chest pain	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
General disorders Injection site plaque	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 284/426 • Number of events 290 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	39.4% 169/429 • Number of events 170 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	54.9% 331/603 • Number of events 338 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Arthralgia	29.6% 126/426 • Number of events 128 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	18.9% 81/429 • Number of events 83 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	27.7% 167/603 • Number of events 171 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.93% 4/429 • Number of events 4 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Pain in extremity	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.70% 3/429 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Bursitis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Limb discomfort	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Pain in jaw	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Headache	46.5% 198/426 • Number of events 200 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	18.2% 78/429 • Number of events 79 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	41.5% 250/603 • Number of events 258 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Dizziness	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.66% 4/603 • Number of events 4 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Parosmia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Tension headache	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Brain fog	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Cubital tunnel syndrome	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Hypoaesthesia	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Paraesthesia	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Ageusia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Dysgeusia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Post-traumatic headache	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Nervous system disorders Sciatica	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Upper respiratory tract infection	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.6% 7/429 • Number of events 7 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.7% 10/603 • Number of events 10 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Nasopharyngitis	1.2% 5/426 • Number of events 5 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.4% 6/429 • Number of events 6 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Sinusitis	0.70% 3/426 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.70% 3/429 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations COVID-19	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.00% 6/603 • Number of events 6 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Gastroenteritis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.00% 6/603 • Number of events 6 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Bronchitis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Urinary tract infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Viral upper respiratory tract infection	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Influenza	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Conjunctivitis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Ear infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Diarrhoea infectious	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Vulvovaginal mycotic infection	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Oral candidiasis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Pharyngitis	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Cellulitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Otitis media	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Rhinovirus infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Tonsillitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Post procedural infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Skin infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Wound infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Hordeolum	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Injection site cellulitis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Laryngitis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Gastroenteritis shigella	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Herpes simplex	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Lower respiratory tract infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Pyelonephritis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Sinusitis bacterial	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Vaginal infection	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Vestibulitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Asthma	1.2% 5/426 • Number of events 5 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.2% 7/603 • Number of events 7 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Cough	0.70% 3/426 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.83% 5/603 • Number of events 5 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	1.00% 6/603 • Number of events 6 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Productive cough	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Nausea	3.3% 14/426 • Number of events 14 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	2.0% 12/603 • Number of events 12 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Vomiting	0.94% 4/426 • Number of events 4 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.50% 3/603 • Number of events 3 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Diarrhoea	0.47% 2/426 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Abdominal pain	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Angular cheilitis	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Gingival pain	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Constipation	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Gastrointestinal disorders Toothache	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Arthropod bite	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Fall	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Contusion	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Craniofacial fracture	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Muscle strain	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Rash	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Blood and lymphatic system disorders Lymphadenopathy	1.4% 6/426 • Number of events 6 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Blood and lymphatic system disorders Lymph node pain	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Psychiatric disorders Anxiety	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Psychiatric disorders Depression	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Psychiatric disorders Bipolar disorder	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Psychiatric disorders Insomnia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Hypoglycaemia	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Dehydration	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Hypertension	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.47% 2/429 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Haematoma	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Essential hypertension	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Hot flush	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Vascular disorders Hypotension	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Reproductive system and breast disorders Abnormal uterine bleeding	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Reproductive system and breast disorders Dysmenorrhoea	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Reproductive system and breast disorders Pelvic pain	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Eye disorders Dry eye	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.33% 2/603 • Number of events 2 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Eye disorders Ocular hyperaemia	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Cardiac disorders Palpitations	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Cardiac disorders Atrial fibrillation	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Ear and labyrinth disorders Auditory disorder	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.23% 1/429 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Ear and labyrinth disorders Vertigo	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Renal and urinary disorders Acute kidney injury	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Renal and urinary disorders Bladder disorder	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Investigations Blood glucose increased	0.23% 1/426 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/603 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Hepatobiliary disorders Metabolic dysfunction-associated liver disease	0.00% 0/426 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.00% 0/429 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.	0.17% 1/603 • Number of events 1 • Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, related SAEs, fatal SAEs and AESIs (including pIMDs and AF) were collected from Day 1 up to study end (Month 6) Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER