Trial Outcomes & Findings for A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002) (NCT NCT00535236)

NCT ID: NCT00535236

Last Updated: 2019-05-20

Results Overview

Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 341 participants
• Primary outcome timeframe: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
• Results posted on: 2019-05-20

Participant Flow

Autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants, participants with solid tumor malignancy (STM) and receiving chemotherapy, and participants with hematologic malignancy (HM) were enrolled in the study.

Participant milestones

Measure	Autologous HCT-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Autologous HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Overall Study STARTED	40	10	41	10	59	20	62	19	60	20
Overall Study Vaccination 1	40	10	40	10	58	19	61	19	60	20
Overall Study Vaccination 2	35	10	37	8	52	19	58	19	57	19
Overall Study Vaccination 3	34	10	35	8	48	19	51	18	53	18
Overall Study Vaccination 4	34	10	32	6	47	19	51	18	50	17
Overall Study COMPLETED	33	8	29	6	47	19	51	18	47	16
Overall Study NOT COMPLETED	7	2	12	4	12	1	11	1	13	4

Reasons for withdrawal

Measure	Autologous HCT-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Autologous HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Overall Study Adverse Event	1	0	9	3	3	0	5	1	2	1
Overall Study Lost to Follow-up	1	2	0	0	2	0	0	0	6	1
Overall Study Physician Decision	0	0	0	0	1	0	1	0	0	0
Overall Study Protocol Violation	2	0	1	0	0	0	0	0	1	0
Overall Study Withdrawal by Subject	3	0	2	1	6	1	5	0	4	2

Baseline Characteristics

A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)

Baseline characteristics by cohort

Measure	Autologous HCT-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Autologous HCT-Placebo n=10 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-V212 n=41 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo n=10 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=59 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=20 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=62 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=20 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Total n=341 Participants Total of all reporting groups
Age, Customized 18 to 49 years	18 Participants n=5 Participants	6 Participants n=7 Participants	27 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	4 Participants n=6 Participants	40 Participants n=6 Participants	14 Participants n=64 Participants	142 Participants n=17 Participants
Age, Customized 50 to 59 years	12 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants	4 Participants n=10 Participants	12 Participants n=115 Participants	3 Participants n=6 Participants	17 Participants n=6 Participants	6 Participants n=64 Participants	83 Participants n=17 Participants
Age, Customized 60 to 69 years	9 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	17 Participants n=21 Participants	4 Participants n=10 Participants	18 Participants n=115 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=64 Participants	67 Participants n=17 Participants
Age, Customized 70 to 79 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	19 Participants n=115 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	35 Participants n=17 Participants
Age, Customized ≥ 80 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	6 Participants n=115 Participants	4 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	14 Participants n=17 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants	1 Participants n=4 Participants	40 Participants n=21 Participants	15 Participants n=10 Participants	23 Participants n=115 Participants	8 Participants n=6 Participants	11 Participants n=6 Participants	4 Participants n=64 Participants	135 Participants n=17 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	7 Participants n=7 Participants	27 Participants n=5 Participants	9 Participants n=4 Participants	19 Participants n=21 Participants	5 Participants n=10 Participants	39 Participants n=115 Participants	11 Participants n=6 Participants	49 Participants n=6 Participants	16 Participants n=64 Participants	206 Participants n=17 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=10 Participants	5 Participants n=115 Participants	1 Participants n=6 Participants	8 Participants n=6 Participants	3 Participants n=64 Participants	41 Participants n=17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	8 Participants n=7 Participants	34 Participants n=5 Participants	9 Participants n=4 Participants	51 Participants n=21 Participants	18 Participants n=10 Participants	57 Participants n=115 Participants	18 Participants n=6 Participants	52 Participants n=6 Participants	17 Participants n=64 Participants	300 Participants n=17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	9 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	20 Participants n=21 Participants	7 Participants n=10 Participants	6 Participants n=115 Participants	2 Participants n=6 Participants	38 Participants n=6 Participants	11 Participants n=64 Participants	91 Participants n=17 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	9 Participants n=7 Participants	36 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants	13 Participants n=10 Participants	55 Participants n=115 Participants	16 Participants n=6 Participants	21 Participants n=6 Participants	9 Participants n=64 Participants	240 Participants n=17 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)

Population: All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination gpELISA data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.

Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

Outcome measures

Measure	STM-V212 n=55 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=59 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)	2.35 Ratio Interval 1.84 to 3.01	1.28 Ratio Interval 1.12 to 1.45	1.37 Ratio Interval 1.11 to 1.7	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)

Population: All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination IFN-g data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.

Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

Outcome measures

Measure	STM-V212 n=56 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay	3.00 Ratio Interval 1.97 to 4.57	2.23 Ratio Interval 1.42 to 3.48	1.76 Ratio Interval 1.17 to 2.67	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 28 days post vaccination 4 (up to ~Day 118)

Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.

An SAE was 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, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.

Outcome measures

Measure	STM-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=10 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo n=10 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=57 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=61 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=20 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)	32.5 Percentage of Participants	20.0 Percentage of Participants	80.0 Percentage of Participants	70.0 Percentage of Participants	12.3 Percentage of Participants	10.5 Percentage of Participants	19.7 Percentage of Participants	5.3 Percentage of Participants	13.3 Percentage of Participants	10.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Day 5 post any vaccination

Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.

An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized.

Outcome measures

Measure	STM-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=10 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo n=10 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=57 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=61 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=20 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)	10.0 Percentage of Participants	10.0 Percentage of Participants	10.0 Percentage of Participants	0.0 Percentage of Participants	36.8 Percentage of Participants	5.3 Percentage of Participants	31.1 Percentage of Participants	10.5 Percentage of Participants	3.3 Percentage of Participants	15.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 28 days post vaccination 4 (up to ~118 days)

Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.

An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized.

Outcome measures

Measure	STM-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=10 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=40 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo n=10 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=57 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=61 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=20 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Percentage of Participants With a Systemic Adverse Event Prompted on the VRC	5.0 Percentage of Participants	10.0 Percentage of Participants	2.5 Percentage of Participants	0.0 Percentage of Participants	3.5 Percentage of Participants	0.0 Percentage of Participants	4.9 Percentage of Participants	0.0 Percentage of Participants	5.0 Percentage of Participants	5.0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 28 days post any vaccination (up to ~118 days)

Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.

Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized.

Outcome measures

Measure	STM-V212 n=38 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=10 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=39 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic HCT-Placebo n=10 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=53 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=58 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=56 Participants Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=19 Participants Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC	60.5 Percentage of Participants	50.0 Percentage of Participants	66.7 Percentage of Participants	60.0 Percentage of Participants	7.5 Percentage of Participants	0.0 Percentage of Participants	12.1 Percentage of Participants	5.3 Percentage of Participants	14.3 Percentage of Participants	10.5 Percentage of Participants

Adverse Events

Autologous HCT-V212

Serious events: 13 serious events

Other events: 40 other events

Deaths: 1 deaths

Autologous HCT-Placebo

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Allogeneic-V212

Serious events: 32 serious events

Other events: 40 other events

Deaths: 11 deaths

Allogeneic-Placebo

Serious events: 7 serious events

Other events: 9 other events

Deaths: 2 deaths

STM-V212

Serious events: 7 serious events

Other events: 38 other events

Deaths: 1 deaths

STM-Placebo

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

HM-V212

Serious events: 12 serious events

Other events: 51 other events

Deaths: 4 deaths

HM-Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

HIV-V212

Serious events: 8 serious events

Other events: 33 other events

Deaths: 1 deaths

HIV-Placebo

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Autologous HCT-V212 n=40 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Autologous HCT-Placebo n=10 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic-V212 n=40 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic-Placebo n=10 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=57 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=19 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=61 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=20 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Infections and infestations Bacteraemia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Anaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Leukopenia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Lymphatic obstruction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Neutropenia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Atrial fibrillation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Endocrine disorders Diabetes insipidus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Nausea	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Oesophagitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Vomiting	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Adverse drug reaction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Mucosal inflammation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Multi-organ failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	17.5% 7/40 • Number of events 9 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Hepatitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Venoocclusive liver disease	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Acute graft versus host disease in intestine	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	12.5% 5/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Acute graft versus host disease in liver	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Graft versus host disease	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Acinetobacter bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Device related infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Escherichia bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Escherichia sepsis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Hepatosplenic candidiasis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Klebsiella bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Meningitis herpes	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Neutropenic sepsis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Peritonitis bacterial	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia fungal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia legionella	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia primary atypical	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia viral	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pseudomonal sepsis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pyelonephritis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Sepsis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Septic shock	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Sinusitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Staphylococcal bacteraemia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Systemic candida	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Wound infection pseudomonas	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Drug toxicity	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Fall	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Overdose	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Alanine aminotransferase increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Aspartate aminotransferase increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood alkaline phosphatase increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood bilirubin increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood lactate dehydrogenase increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Epstein-Barr virus test positive	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations White blood cell count decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Malnutrition	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma recurrent	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epstein-Barr virus associated lymphoproliferative disorder	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease recurrent	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrent cancer	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Convulsion	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Syncope	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Transient ischaemic attack	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Mental status changes	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Haematuria	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Nephrolithiasis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Renal failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Renal failure acute	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Circulatory collapse	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Hypotension	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.

Other adverse events

Measure	Autologous HCT-V212 n=40 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Autologous HCT-Placebo n=10 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic-V212 n=40 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	Allogeneic-Placebo n=10 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-V212 n=57 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	STM-Placebo n=19 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-V212 n=61 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HM-Placebo n=19 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-V212 n=60 participants at risk Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.	HIV-Placebo n=20 participants at risk Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Visual impairment	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal distension	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal pain	15.0% 6/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	60.0% 6/10 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	25.0% 10/40 • Number of events 11 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Wheezing	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Acne	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Alopecia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Cytomegalovirus viraemia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	15.0% 6/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Drug eruption	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Dry skin	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Periorbital oedema	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Ecchymosis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Erythema	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Upper respiratory tract infection	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	11.5% 7/61 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 3/60 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Vitreous floaters	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Petechiae	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Photosensitivity reaction	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Anaemia	22.5% 9/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	70.0% 7/10 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	27.5% 11/40 • Number of events 14 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Coagulopathy	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Febrile neutropenia	45.0% 18/40 • Number of events 18 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	50.0% 5/10 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	25.0% 10/40 • Number of events 10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	40.0% 4/10 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Leukopenia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Lymphatic obstruction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Neutropenia	55.0% 22/40 • Number of events 24 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	60.0% 6/10 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	22.5% 9/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	15.8% 3/19 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Pancytopenia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Thrombocytopenia	45.0% 18/40 • Number of events 21 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	80.0% 8/10 • Number of events 8 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 12/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Acute myocardial infarction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Angina pectoris	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Atrial fibrillation	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Atrial flutter	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Atrioventricular block	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Atrioventricular block first degree	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Cardiac failure congestive	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Cardiomegaly	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Cardiomyopathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Intracardiac thrombus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Mitral valve incompetence	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Palpitations	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Pericardial effusion	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Sinus bradycardia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Sinus tachycardia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Supraventricular tachycardia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Tachycardia	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Ventricular extrasystoles	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Cardiac disorders Ventricular tachycardia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Ear and labyrinth disorders Deafness neurosensory	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Ear and labyrinth disorders Ear congestion	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Ear and labyrinth disorders Ear pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Ear and labyrinth disorders Tinnitus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Ear and labyrinth disorders Vertigo	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Endocrine disorders Goitre	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Endocrine disorders Hyperthyroidism	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Endocrine disorders Hypothyroidism	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Conjunctival haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Conjunctivochalasis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Diplopia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Eye movement disorder	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Eye oedema	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Eye pain	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Eyelid cyst	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Eyelid ptosis	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Keratopathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Lacrimation increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Ocular discomfort	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Ocular hyperaemia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Ocular icterus	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Photophobia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Eye disorders Vision blurred	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Anorectal discomfort	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Ascites	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Chapped lips	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Cheilitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Colitis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Colonic polyp	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Constipation	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	40.0% 4/10 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 8/40 • Number of events 8 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Diarrhoea	57.5% 23/40 • Number of events 24 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	100.0% 10/10 • Number of events 10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	50.0% 20/40 • Number of events 24 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	50.0% 5/10 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.8% 5/57 • Number of events 8 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	14.8% 9/61 • Number of events 20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.3% 5/60 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Dry mouth	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Dyspepsia	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Dysphagia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Flatulence	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Gastritis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Gingival bleeding	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Glossodynia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Haematemesis	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Haematochezia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Haemorrhoids	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Hiatus hernia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Ileus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Lip haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Lip pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Lip ulceration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Localised intraabdominal fluid collection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Mouth ulceration	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Nausea	50.0% 20/40 • Number of events 22 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	70.0% 7/10 • Number of events 8 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	45.0% 18/40 • Number of events 20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	40.0% 4/10 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.8% 5/57 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	9.8% 6/61 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	21.1% 4/19 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Odynophagia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Oral disorder	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Oral mucosal erythema	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Oral pain	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Pancreatitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Peritonitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Proctalgia	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Salivary hypersecretion	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Small intestinal obstruction	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Stomatitis	32.5% 13/40 • Number of events 13 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	40.0% 4/10 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	27.5% 11/40 • Number of events 11 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Tongue discolouration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Tongue ulceration	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Gastrointestinal disorders Vomiting	30.0% 12/40 • Number of events 13 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	25.0% 10/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Adverse drug reaction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Asthenia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Axillary pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Catheter site discharge	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Catheter site erythema	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Catheter site haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Catheter site inflammation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Catheter site pain	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Chest discomfort	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Chest pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Chills	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Cyst rupture	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Fatigue	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	14.0% 8/57 • Number of events 9 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	21.1% 4/19 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Generalised oedema	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Hypothermia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site discolouration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site erythema	10.0% 4/40 • Number of events 10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	29.8% 17/57 • Number of events 37 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	23.0% 14/61 • Number of events 33 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 2/20 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site haematoma	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site mass	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site pain	7.5% 3/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	33.3% 19/57 • Number of events 42 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	23.0% 14/61 • Number of events 31 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	15.0% 3/20 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site papule	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site pruritus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site swelling	7.5% 3/40 • Number of events 8 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	26.3% 15/57 • Number of events 36 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	21.3% 13/61 • Number of events 31 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 2/20 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Injection site warmth	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Local swelling	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Medical device pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Mucosal haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Mucosal inflammation	27.5% 11/40 • Number of events 11 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	32.5% 13/40 • Number of events 13 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Mucosal ulceration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Non-cardiac chest pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Oedema	10.0% 4/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Oedema peripheral	15.0% 6/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	27.5% 11/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	6.6% 4/61 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Pain	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Pyrexia	55.0% 22/40 • Number of events 25 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	40.0% 4/10 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	65.0% 26/40 • Number of events 43 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	70.0% 7/10 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 6/57 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	14.8% 9/61 • Number of events 9 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	13.3% 8/60 • Number of events 14 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 2/20 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Suprapubic pain	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Swelling	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Temperature intolerance	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Tenderness	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
General disorders Thrombosis in device	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Hepatic steatosis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Hepatobiliary disorders Hyperbilirubinaemia	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	15.0% 6/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Acute graft versus host disease	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Acute graft versus host disease in intestine	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Acute graft versus host disease in skin	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 12/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	40.0% 4/10 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Drug hypersensitivity	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Graft versus host disease	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Immune system disorders Seasonal allergy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Acute sinusitis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Bronchitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Bronchitis bacterial	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Candidiasis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Catheter site infection	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Cellulitis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Chronic sinusitis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Clostridium difficile colitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	12.5% 5/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Conjunctivitis infective	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Corona virus infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Cystitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Cytomegalovirus colitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Cytomegalovirus infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Enterococcal bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Enterocolitis infectious	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Escherichia bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Escherichia urinary tract infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Eye infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Folliculitis	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Fungaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Fungal infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Fungal skin infection	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Furuncle	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Genital herpes	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Gingival infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Herpes simplex	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Herpes zoster	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Influenza	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Klebsiella bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Lower respiratory tract infection	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Lung infection pseudomonal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Lyme disease	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Nasopharyngitis	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Oesophageal candidiasis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Oral candidiasis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Oral herpes	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Otitis media	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Parainfluenzae virus infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pharyngitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia bacterial	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia fungal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia haemophilus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pneumonia staphylococcal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Rhinitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Rhinovirus infection	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Sinusitis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Staphylococcal bacteraemia	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Staphylococcal infection	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Streptococcal bacteraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Subcutaneous abscess	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Tinea infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Tooth abscess	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Urinary tract infection	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Urinary tract infection bacterial	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Infections and infestations Urosepsis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Allergic transfusion reaction	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Anal injury	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Arthropod bite	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Contusion	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Excoriation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Fall	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Rib fracture	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Tongue injury	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Transfusion reaction	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Wound complication	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Alanine aminotransferase increased	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Aspartate aminotransferase increased	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Bacterial test positive	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood creatinine increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood glucose increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood lactate dehydrogenase increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood magnesium increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood pressure increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Blood uric acid increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Cardiac murmur	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Clostridium test positive	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Crystal urine present	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Electrocardiogram QT prolonged	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Haematocrit decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Haemoglobin decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Heart sounds abnormal	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Lymphocyte count decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Mean platelet volume decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Neutrophil count decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Platelet count decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Prostatic specific antigen increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Pulmonary function test decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Red blood cell count decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Sputum abnormal	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Troponin increased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Urine output decreased	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Viral test positive	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Vitamin D decreased	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations Weight decreased	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Investigations White blood cell count decreased	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Decreased appetite	15.0% 6/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Dehydration	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Fluid overload	12.5% 5/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Gout	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyperglycaemia	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	15.0% 6/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypocalcaemia	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypokalaemia	30.0% 12/40 • Number of events 13 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 8/40 • Number of events 10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypomagnesaemia	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	27.5% 11/40 • Number of events 11 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	12.5% 5/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hypophosphataemia	17.5% 7/40 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Malnutrition	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Metabolic acidosis	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.2% 5/61 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Back pain	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.2% 5/61 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Groin pain	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Muscle spasms	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Neck mass	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Nodule on extremity	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 2/20 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile wart	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Balance disorder	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Cerebral haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Cognitive disorder	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Dementia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Depressed level of consciousness	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Dizziness	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.2% 5/61 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Dizziness postural	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Dysarthria	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Dysgeusia	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Dysstasia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Encephalopathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Facial palsy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Headache	20.0% 8/40 • Number of events 8 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 12/40 • Number of events 13 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.0% 4/57 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	9.8% 6/61 • Number of events 9 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	6.7% 4/60 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Hemiparesis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Hypoaesthesia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Lethargy	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Loss of consciousness	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Memory impairment	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Motor dysfunction	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Neuralgia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Neuropathy peripheral	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Paraesthesia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Peroneal nerve palsy	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Cystitis haemorrhagic	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Pneumocephalus	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Sinus headache	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Syncope	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Nervous system disorders Tremor	5.0% 2/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Agitation	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Anxiety	12.5% 5/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Catatonia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Confusional state	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Delirium	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Depression	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Hallucination, visual	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Insomnia	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	32.5% 13/40 • Number of events 14 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Mental status changes	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Psychomotor retardation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Restlessness	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Seasonal affective disorder	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Psychiatric disorders Sleep disorder	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Azotaemia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Bladder pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Dysuria	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Haematuria	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Nocturia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Pollakiuria	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Renal failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Renal failure acute	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	37.5% 15/40 • Number of events 18 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Urethral pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Urinary hesitation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Urinary incontinence	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Renal and urinary disorders Urinary retention	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Genital erythema	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Genital lesion	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Menorrhagia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Penile exfoliation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Penile pain	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Scrotal oedema	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Scrotal pain	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Reproductive system and breast disorders Vulvovaginal pruritus	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.5% 1/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 5/40 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	12.5% 5/40 • Number of events 6 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	6.6% 4/61 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/60 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	15.0% 3/20 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.5% 2/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	50.0% 5/10 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Pruritus	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Pruritus generalised	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash	17.5% 7/40 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 8/40 • Number of events 12 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	20.0% 2/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 3/57 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	8.2% 5/61 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 3/60 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 2/20 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash follicular	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash generalised	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.7% 1/60 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash macular	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash papular	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 5 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash pruritic	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Rash vesicular	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 3/60 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 1/20 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Skin exfoliation	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Swelling face	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Urticaria	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 4/40 • Number of events 4 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.3% 2/61 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Deep vein thrombosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	7.5% 3/40 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Diastolic hypertension	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Flushing	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Haematoma	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Hot flush	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Hypertension	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	12.5% 5/40 • Number of events 7 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Hypotension	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	30.0% 3/10 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.0% 2/40 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.8% 1/57 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	4.9% 3/61 • Number of events 3 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Orthostatic hypotension	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	10.0% 1/10 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Peripheral embolism	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	2.5% 1/40 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Phlebitis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	3.5% 2/57 • Number of events 2 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Thrombophlebitis superficial	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	1.6% 1/61 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Vasodilatation	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.
Vascular disorders Venous thrombosis	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/40 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/10 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/57 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	5.3% 1/19 • Number of events 1 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/61 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/19 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/60 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.	0.00% 0/20 • Up to 28 days post vaccination 4 (~118 days) Population included all participants that received at least 1 vaccination and had follow-up safety data available.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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