Trial Outcomes & Findings for A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED) (NCT NCT00696709)

Last Updated: 2019-11-08

Results Overview

Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

290 participants

Primary outcome timeframe

Baseline and ~28 days Postdose 4 (~Day 118)

Results posted on

2019-11-08

Participant Flow

The study was performed in 2 parts - Part 1 and Part 2, with a total of 160 participants.

In Part 1, all participants received heat-treated varicella zoster virus (VZV) vaccine, gamma-irradiated VZV vaccine A or placebo administered as a 4-dose regimen approximately every 30 days. In Part 2, all participants received either gamma-irradiated VZV vaccine B or C administered as a 4-dose regimen approximately every 30 days.

Participant milestones

Participant milestones
Measure	Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Overall Study STARTED	65	63	33	64	65
Overall Study Vaccination 1 (Day 1)	65	63	32	64	65
Overall Study Vaccination 2 (~Day 30)	64	60	32	61	64
Overall Study Vaccination 3 (~Day 60)	64	60	32	59	63
Overall Study Vaccination 4 (~Day 90)	62	60	32	59	63
Overall Study COMPLETED	62	60	32	59	62
Overall Study NOT COMPLETED	3	3	1	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Overall Study Withdrawal by Subject	1	2	1	4	3
Overall Study Protocol Violation	1	0	0	0	0
Overall Study Lost to Follow-up	1	1	0	0	0
Overall Study Adverse Event	0	0	0	1	0

Baseline Characteristics

A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine n=65 Participants Participants received an 0.65 mL subcutaneous injection of heat-treated VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo n=33 Participants Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B n=64 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C n=65 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.	Total n=290 Participants Total of all reporting groups
Age, Continuous	54.0 Years STANDARD_DEVIATION 2.6 • n=5 Participants	54.0 Years STANDARD_DEVIATION 2.5 • n=7 Participants	54.0 Years STANDARD_DEVIATION 2.9 • n=5 Participants	53.9 Years STANDARD_DEVIATION 3.0 • n=4 Participants	54.6 Years STANDARD_DEVIATION 3.1 • n=21 Participants	54.1 Years STANDARD_DEVIATION 2.8 • n=10 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	45 Participants n=7 Participants	25 Participants n=5 Participants	42 Participants n=4 Participants	37 Participants n=21 Participants	193 Participants n=10 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	18 Participants n=7 Participants	8 Participants n=5 Participants	22 Participants n=4 Participants	28 Participants n=21 Participants	97 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and ~28 days Postdose 4 (~Day 118)

Population: The analysis population included all gamma-irradiated VZV vaccine A participants who received all 4 vaccinations with no protocol deviations; heat-treated VZV vaccine, vaccine B, vaccine C and placebo participants were not assessed for this outcome.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=59 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients	2.18 Ratio Interval 1.82 to 2.61	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and ~28 days Postdose 4 (~Day 118)

Population: The analysis population included all gamma-irradiated VZV vaccine B participants who received all 4 vaccinations with no protocol deviations; heat-treated VZV vaccine, vaccine A, vaccine C and placebo participants were not assessed for this outcome.

Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=59 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients	1.90 Ratio Interval 1.57 to 2.29	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and ~28 days Postdose 4 (~Day 118)

Population: The analysis population included all gamma-irradiated VZV vaccine C participants who received all 4 vaccinations and had no protocol deviations; heat-treated VZV vaccine, vaccine A, vaccine B and placebo participants were not assessed for this outcome.

Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients	1.58 Ratio Interval 1.35 to 1.84	—	—	—	—

PRIMARY outcome

Timeframe: Up to ~28 days Postdose 4 (Up to ~118 days)

Population: The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination.

A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=64 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A n=61 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo n=32 Participants Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C n=65 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Percentage of Participants With a Serious Adverse Event	0.0 Percentage of Participants	1.6 Percentage of Participants	0.0 Percentage of Participants	1.6 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Day 5 post any vaccination (Up to ~5 days)

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence \> 0% in one or more vaccination groups.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=64 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A n=61 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo n=32 Participants Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C n=65 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card	57.8 Percentage of Participants	62.3 Percentage of Participants	21.9 Percentage of Participants	63.5 Percentage of Participants	50.8 Percentage of Participants

PRIMARY outcome

Timeframe: Up to ~28 days Postdose 4 (Up to ~118 days)

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence \> 0% in one or more vaccination groups.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=64 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A n=61 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo n=32 Participants Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C n=65 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card	45.3 Percentage of Participants	54.1 Percentage of Participants	50.0 Percentage of Participants	52.4 Percentage of Participants	41.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to ~28 days Postdose 4 (Up to ~118 days)

Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=64 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A n=61 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo n=32 Participants Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C n=65 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card	1.6 Percentage of Participants	1.6 Percentage of Participants	0.0 Percentage of Participants	3.2 Percentage of Participants	1.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Dose 4 (Up to ~90 days)

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=64 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A n=61 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo n=32 Participants Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B n=63 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C n=65 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	1.6 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and ~28 days Postdose 4 (~Day 118)

Population: The analysis population included all heat-treated VZV vaccine participants who received all 4 vaccinations and had no protocol deviations; vaccine A, vaccine B, vaccine C and placebo participants were not assessed for this outcome.

Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.

Outcome measures

Outcome measures
Measure	Part 1: Gamma- Irradiated VZV Vaccine A n=62 Participants Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Gamma-Irradiated VZV Vaccine A Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered \~30 days apart.	Part 1: Placebo Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine B Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered \~30 days apart.	Part 2: Gamma-Irradiated VZV Vaccine C Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered \~30 days apart.
Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA	2.10 Ratio Interval 1.78 to 2.48	—	—	—	—

Adverse Events

Part 1 Heat-treated VZV Vaccine

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Gamma-irradiated VZV Vaccine A

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Part 2 Gamma-irradiated VZV Vaccine B

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Gamma-irradiated VZV Vaccine C

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 Heat-treated VZV Vaccine n=64 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.	Gamma-irradiated VZV Vaccine A n=61 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.	Placebo n=32 participants at risk Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2 Gamma-irradiated VZV Vaccine B n=63 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.	Gamma-irradiated VZV Vaccine C n=65 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.
General disorders Chest pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.

Other adverse events

Other adverse events
Measure	Part 1 Heat-treated VZV Vaccine n=64 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.	Gamma-irradiated VZV Vaccine A n=61 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.	Placebo n=32 participants at risk Participants received a 4-dose placebo regimen administered \~30 days apart.	Part 2 Gamma-irradiated VZV Vaccine B n=63 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.	Gamma-irradiated VZV Vaccine C n=65 participants at risk Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Dermatitis contact	4.7% 3/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.6% 3/65 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Erythema	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Eye disorders Scleral disorder	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Cardiac disorders Palpitations	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Ear and labyrinth disorders Ear pain	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Ear and labyrinth disorders Tinnitus	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Ear and labyrinth disorders Vertigo	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Endocrine disorders Hypothyroidism	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Eye disorders Eye allergy	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Abdominal pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Abdominal pain upper	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Constipation	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Dental caries	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Diarrhoea	4.7% 3/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Dry mouth	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Dyspepsia	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Flatulence	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Nausea	4.7% 3/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Toothache	1.6% 1/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Gastrointestinal disorders Vomiting	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Axillary pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Chest pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Chills	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Fatigue	3.1% 2/64 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.8% 3/63 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Feeling hot	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Influenza like illness	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site erythema	45.3% 29/64 • Number of events 73 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	50.8% 31/61 • Number of events 73 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.2% 2/32 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	44.4% 28/63 • Number of events 69 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	41.5% 27/65 • Number of events 73 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site haematoma	6.2% 4/64 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	8.2% 5/61 • Number of events 6 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	7.9% 5/63 • Number of events 5 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site induration	4.7% 3/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site pain	50.0% 32/64 • Number of events 80 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	59.0% 36/61 • Number of events 79 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	21.9% 7/32 • Number of events 7 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	63.5% 40/63 • Number of events 86 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	49.2% 32/65 • Number of events 73 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site papule	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site pruritus	15.6% 10/64 • Number of events 13 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	11.5% 7/61 • Number of events 12 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	11.1% 7/63 • Number of events 11 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	7.7% 5/65 • Number of events 8 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site rash	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.9% 3/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site swelling	45.3% 29/64 • Number of events 66 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	32.8% 20/61 • Number of events 42 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	9.4% 3/32 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	38.1% 24/63 • Number of events 53 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	36.9% 24/65 • Number of events 60 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Injection site warmth	6.2% 4/64 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.3% 4/63 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.6% 3/65 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Local swelling	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Malaise	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Pain	4.7% 3/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Pyrexia	3.1% 2/64 • Number of events 5 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.6% 3/65 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
General disorders Vessel puncture site pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Hepatobiliary disorders Biliary colic	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Immune system disorders Allergy to arthropod bite	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Immune system disorders Anaphylactic reaction	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Acute sinusitis	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Bed bug infestation	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Bronchitis	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Cellulitis	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Clostridial infection	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Conjunctivitis infective	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Cystitis	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Ear infection	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Folliculitis	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Gastroenteritis viral	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Herpes simplex	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Herpes zoster	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Hordeolum	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Influenza	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.9% 3/61 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Kidney infection	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Nasopharyngitis	4.7% 3/64 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	8.2% 5/61 • Number of events 6 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	9.4% 3/32 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.6% 3/65 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Oral herpes	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Pharyngitis	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Sinusitis	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.9% 3/61 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	9.4% 3/32 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Tonsillitis	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Tooth abscess	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Tooth infection	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Upper respiratory tract infection	3.1% 2/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.6% 4/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Urinary tract infection	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Infections and infestations Viral infection	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 5 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Contusion	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Limb injury	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Muscle strain	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Skin laceration	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.9% 3/61 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Injury, poisoning and procedural complications Wound complication	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Investigations Blood pressure increased	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Metabolism and nutrition disorders Gout	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.8% 3/63 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Back pain	4.7% 3/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.6% 4/61 • Number of events 5 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.8% 3/63 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.6% 1/64 • Number of events 8 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 2/64 • Number of events 9 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.6% 4/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Nodule on extremity	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.6% 3/65 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Nervous system disorders Dizziness	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Nervous system disorders Headache	7.8% 5/64 • Number of events 10 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	9.8% 6/61 • Number of events 9 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	9.4% 3/32 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	14.3% 9/63 • Number of events 19 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	12.3% 8/65 • Number of events 19 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Nervous system disorders Hypoaesthesia	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Nervous system disorders Migraine	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Nervous system disorders Paraesthesia	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Nervous system disorders Sinus headache	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Psychiatric disorders Anxiety	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Psychiatric disorders Generalised anxiety disorder	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Psychiatric disorders Insomnia	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Renal and urinary disorders Nephrolithiasis	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Renal and urinary disorders Renal failure acute	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Reproductive system and breast disorders Breast pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.6% 4/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.6% 4/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	4.8% 3/63 • Number of events 5 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 7 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Acne	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Blister	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Dermatitis	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Dermatitis acneiform	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Pruritus	3.1% 2/64 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	6.3% 4/63 • Number of events 6 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Rash	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 4 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 2/65 • Number of events 3 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.5% 1/65 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Rash vesicular	3.1% 2/64 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.3% 2/61 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.1% 1/32 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	3.2% 2/63 • Number of events 2 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Skin swelling	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/61 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Skin and subcutaneous tissue disorders Urticaria	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/63 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Vascular disorders Hot flush	0.00% 0/64 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.
Vascular disorders Hypertension	1.6% 1/64 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	1.6% 1/61 • Number of events 1 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/32 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/63 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.	0.00% 0/65 • Up to ~28 days Postdose 4 (up to ~118 days) All participants who received at least one dose of vaccine and who had any safety follow-up were included in the safety evaluation, based on the actual vaccination received. Participants were excluded from the safety analysis population if they received an incorrect vaccination.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER