Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older (NCT NCT03502707)

Last Updated: 2025-05-25

Results Overview

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

669 participants

Primary outcome timeframe

From Day 1 up to Day 730

Results posted on

2025-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Pooled Placebo Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.	Cohort 1: RSV preF Protein 50 mcg Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 50 mcg (Mixture) Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5\10\^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2:Ad26.RSV.preF 510^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.	Cohort 2:Ad26.RSV.preF 110^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Overall Study STARTED	16	8	8	8	8	8	8	24	42	42	42	43	36	36	24	135	136	45
Overall Study Randomized and Vaccinated (Full Analysis Set)	16	8	8	8	8	8	8	24	42	42	42	42	36	36	24	135	136	44
Overall Study COMPLETED	14	7	8	7	8	6	8	16	37	34	27	17	29	32	20	76	75	24
Overall Study NOT COMPLETED	2	1	0	1	0	2	0	8	5	8	15	26	7	4	4	59	61	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Pooled Placebo Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.	Cohort 1: RSV preF Protein 50 mcg Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2:Ad26.RSV.preF 510^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.	Cohort 2:Ad26.RSV.preF 110^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Overall Study Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	1	5	0
Overall Study Death	0	0	1	0	0	1	1	0	0	1	0	0	1	0	0
Overall Study Lost to Follow-up	0	0	0	0	5	0	2	1	2	1	1	0	4	9	2
Overall Study Physician Decision	0	0	0	0	0	2	1	0	0	0	0	1	3	0	0
Overall Study Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	1	1	0	2	3	1	2	12	23	5	3	3	43	44	18
Overall Study Sponsor's Decision	1	0	0	0	0	0	1	0	0	0	0	0	2	1	0
Overall Study Initiated Prohibited Medication	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Overall Study Other	0	0	0	0	0	1	1	2	0	0	0	0	4	1	0
Overall Study Randomized but not vaccinated	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Pooled Placebo n=16 Participants Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.	Cohort 1: RSV preF Protein 50 mcg n=8 Participants Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 50 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5\10\^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2:Ad26.RSV.preF 510^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.	Cohort 2:Ad26.RSV.preF 110^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.	Cohort 2: Pooled Placebo n=24 Participants Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) n=135 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo n=136 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Total n=667 Participants Total of all reporting groups
Age, Continuous	67.4 years STANDARD_DEVIATION 7.22 • n=5 Participants	67 years STANDARD_DEVIATION 6.05 • n=7 Participants	67.4 years STANDARD_DEVIATION 6.21 • n=5 Participants	69.4 years STANDARD_DEVIATION 6.23 • n=4 Participants	67.3 years STANDARD_DEVIATION 3.88 • n=21 Participants	64.5 years STANDARD_DEVIATION 3.78 • n=10 Participants	66.1 years STANDARD_DEVIATION 6.17 • n=115 Participants	68.5 years STANDARD_DEVIATION 6.29 • n=24 Participants	69 years STANDARD_DEVIATION 6.9 • n=42 Participants	68.5 years STANDARD_DEVIATION 6.96 • n=42 Participants	67.5 years STANDARD_DEVIATION 5.71 • n=42 Participants	71 years STANDARD_DEVIATION 7.58 • n=42 Participants	69 years STANDARD_DEVIATION 6.49 • n=36 Participants	66.5 years STANDARD_DEVIATION 5.03 • n=36 Participants	69 years STANDARD_DEVIATION 7.08 • n=24 Participants	67.9 years STANDARD_DEVIATION 6.43 • n=135 Participants	68.4 years STANDARD_DEVIATION 6.25 • n=136 Participants	69.3 years STANDARD_DEVIATION 6.12 • n=44 Participants	68.3 years STANDARD_DEVIATION 6.4 • n=667 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	13 Participants n=24 Participants	24 Participants n=42 Participants	27 Participants n=42 Participants	28 Participants n=42 Participants	27 Participants n=42 Participants	20 Participants n=36 Participants	28 Participants n=36 Participants	13 Participants n=24 Participants	83 Participants n=135 Participants	78 Participants n=136 Participants	24 Participants n=44 Participants	400 Participants n=667 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	11 Participants n=24 Participants	18 Participants n=42 Participants	15 Participants n=42 Participants	14 Participants n=42 Participants	15 Participants n=42 Participants	16 Participants n=36 Participants	8 Participants n=36 Participants	11 Participants n=24 Participants	52 Participants n=135 Participants	58 Participants n=136 Participants	20 Participants n=44 Participants	267 Participants n=667 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=36 Participants	1 Participants n=36 Participants	4 Participants n=24 Participants	3 Participants n=135 Participants	9 Participants n=136 Participants	1 Participants n=44 Participants	38 Participants n=667 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=10 Participants	8 Participants n=115 Participants	22 Participants n=24 Participants	41 Participants n=42 Participants	39 Participants n=42 Participants	36 Participants n=42 Participants	39 Participants n=42 Participants	32 Participants n=36 Participants	35 Participants n=36 Participants	20 Participants n=24 Participants	132 Participants n=135 Participants	127 Participants n=136 Participants	43 Participants n=44 Participants	628 Participants n=667 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=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 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	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	4 Participants n=667 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	2 Participants n=135 Participants	1 Participants n=136 Participants	2 Participants n=44 Participants	13 Participants n=667 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 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=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	5 Participants n=36 Participants	3 Participants n=24 Participants	11 Participants n=135 Participants	16 Participants n=136 Participants	0 Participants n=44 Participants	62 Participants n=667 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	20 Participants n=24 Participants	37 Participants n=42 Participants	40 Participants n=42 Participants	38 Participants n=42 Participants	36 Participants n=42 Participants	34 Participants n=36 Participants	31 Participants n=36 Participants	21 Participants n=24 Participants	121 Participants n=135 Participants	117 Participants n=136 Participants	41 Participants n=44 Participants	581 Participants n=667 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=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	1 Participants n=44 Participants	5 Participants n=667 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=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants
Region of Enrollment UNITED STATES	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=10 Participants	8 Participants n=115 Participants	24 Participants n=24 Participants	42 Participants n=42 Participants	42 Participants n=42 Participants	42 Participants n=42 Participants	42 Participants n=42 Participants	36 Participants n=36 Participants	36 Participants n=36 Participants	24 Participants n=24 Participants	135 Participants n=135 Participants	136 Participants n=136 Participants	44 Participants n=44 Participants	667 Participants n=667 Participants

PRIMARY outcome

Timeframe: From Day 1 up to Day 730

Population: The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)	0 Participants	3 Participants	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From Day 1 up to Day 730

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=42 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=36 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=36 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=24 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)	—	0 Participants	5 Participants	5 Participants	7 Participants	3 Participants	4 Participants	—

PRIMARY outcome

Timeframe: From Day 1 up to Day 1095

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)	—	4 Participants	5 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 up to Day 1095

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=135 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=136 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)	—	14 Participants	16 Participants	3 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 Solicited Systemic AEs	5 Participants	4 Participants	0 Participants	4 Participants	1 Participants	4 Participants	5 Participants	—
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 Solicited Local AEs	6 Participants	3 Participants	2 Participants	4 Participants	0 Participants	5 Participants	6 Participants	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 2 on Day 57 (Day 64)

Population: The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=15 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=6 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 Solicited Local AEs	0 Participants	5 Participants	1 Participants	3 Participants	2 Participants	3 Participants	7 Participants	—
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 Solicited Systemic AEs	1 Participants	5 Participants	0 Participants	1 Participants	3 Participants	4 Participants	3 Participants	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 3 on Day 365 (Day 372)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=11 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=7 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=7 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=6 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 Solicited Local AEs	6 Participants	1 Participants	0 Participants	3 Participants	2 Participants	4 Participants	5 Participants	—
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 Solicited Systemic AEs	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	5 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=42 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo n=24 Participants Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 Solicited Local AEs	22 Participants	14 Participants	24 Participants	26 Participants	29 Participants	25 Participants	20 Participants	5 Participants
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 Solicited Systemic AEs	20 Participants	11 Participants	23 Participants	20 Participants	22 Participants	21 Participants	20 Participants	11 Participants

PRIMARY outcome

Timeframe: 7 days post-vaccination 2 on Day 57 (Day 64)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=35 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=23 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=40 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=38 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=33 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo n=23 Participants Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 Solicited Local AEs	23 Participants	1 Participants	0 Participants	3 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 Solicited Systemic AEs	13 Participants	3 Participants	9 Participants	8 Participants	7 Participants	5 Participants	5 Participants	6 Participants

PRIMARY outcome

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=134 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=136 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 Solicited Local AEs	—	95 Participants	94 Participants	9 Participants	—	—	—	—
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1 Solicited Systemic AEs	—	95 Participants	88 Participants	12 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 2 on Day 365 (Day 372)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=112 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=114 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=38 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 Solicited Local AEs	—	74 Participants	23 Participants	6 Participants	—	—	—	—
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2 Solicited Systemic AEs	—	56 Participants	38 Participants	10 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 3 on Day 730 (Day 737)

Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=73 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=73 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=25 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 Solicited Local AEs	—	42 Participants	48 Participants	4 Participants	—	—	—	—
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3 Solicited Systemic AEs	—	32 Participants	46 Participants	6 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 28 days post-vaccination 1 on Day 1 (Day 29)

Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1	3 Participants	2 Participants	5 Participants	0 Participants	1 Participants	3 Participants	4 Participants	—

PRIMARY outcome

Timeframe: 28 days post-vaccination 2 on Day 57 (Day 85)

Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=15 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=6 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	2 Participants	4 Participants	—

PRIMARY outcome

Timeframe: 28 days post-vaccination 3 on Day 365 (Day 393)

Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=11 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=7 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=7 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=6 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: 28 days post-vaccination 1 on Day 1 (Day 29)

Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=42 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo n=24 Participants Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1	12 Participants	8 Participants	11 Participants	10 Participants	12 Participants	8 Participants	10 Participants	3 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination 2 on Day 57 (Day 85)

Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=35 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=23 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=40 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=38 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=33 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo n=23 Participants Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2	5 Participants	6 Participants	5 Participants	5 Participants	6 Participants	2 Participants	3 Participants	8 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination 1 on Day 1 (Day 29)

Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=134 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=136 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1	—	32 Participants	23 Participants	7 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 28 days post-vaccination 2 on Day 365 (Day 393)

Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=112 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=114 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=38 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2	—	9 Participants	10 Participants	4 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 28 days post-vaccination 3 on Day 730 (Day 758)

Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=73 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=73 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=25 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3	—	8 Participants	8 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Day 29

Population: The per-protocol RSV immunogenicity (PPI) set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=22 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=40 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=42 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29	—	1642 Titers Interval 1165.0 to 2312.0	2869 Titers Interval 1964.0 to 4193.0	4813 Titers Interval 3642.0 to 6361.0	5189 Titers Interval 3730.0 to 7219.0	4855 Titers Interval 3865.0 to 6099.0	—	—

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547

Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.

RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 183	2073 Titers Interval 798.0 to 5389.0	529 Titers Interval 324.0 to 864.0	2473 Titers Interval 882.0 to 6934.0	3889 Titers Interval 1691.0 to 8943.0	2444 Titers Interval 1186.0 to 5035.0	3438 Titers Interval 1505.0 to 7857.0	2759 Titers Interval 1388.0 to 5483.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 365	1665 Titers Interval 714.0 to 3884.0	502 Titers Interval 350.0 to 719.0	595 Titers Interval 60.0 to 5857.0	2628 Titers Interval 889.0 to 7770.0	1395 Titers Interval 997.0 to 1952.0	2531 Titers Interval 1303.0 to 4915.0	2039 Titers Interval 1148.0 to 3621.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 1	522 Titers Interval 252.0 to 1082.0	553 Titers Interval 369.0 to 831.0	600 Titers Interval 301.0 to 1196.0	917 Titers Interval 474.0 to 1773.0	434 Titers Interval 301.0 to 625.0	457 Titers Interval 291.0 to 718.0	577 Titers Interval 364.0 to 915.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 15	7782 Titers Interval 3715.0 to 16302.0	197 Titers Interval 103.0 to 378.0	4850 Titers Interval 2464.0 to 9547.0	823 Titers Interval 419.0 to 1620.0	644 Titers Interval 106.0 to 3919.0	1152 Titers Interval 640.0 to 2073.0	4404 Titers Interval 2122.0 to 9139.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 29	3678 Titers Interval 1724.0 to 7848.0	412 Titers Interval 268.0 to 632.0	3326 Titers Interval 1643.0 to 6732.0	5716 Titers Interval 2862.0 to 11416.0	4311 Titers Interval 1856.0 to 10016.0	5933 Titers Interval 3603.0 to 9770.0	2399 Titers Interval 1075.0 to 5352.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 57	3980 Titers Interval 1990.0 to 7964.0	431 Titers Interval 288.0 to 646.0	3441 Titers Interval 1634.0 to 7245.0	5105 Titers Interval 2239.0 to 11639.0	3382 Titers Interval 1352.0 to 8460.0	5276 Titers Interval 2798.0 to 9947.0	3382 Titers Interval 1697.0 to 6738.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 85	3905 Titers Interval 1414.0 to 10788.0	536 Titers Interval 348.0 to 827.0	4142 Titers Interval 2147.0 to 7991.0	4865 Titers Interval 1787.0 to 13248.0	4574 Titers Interval 2506.0 to 8346.0	4582 Titers Interval 2203.0 to 9531.0	4667 Titers Interval 2660.0 to 8189.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 393	3081 Titers Interval 1252.0 to 7581.0	442 Titers Interval 313.0 to 623.0	2548 Titers Interval 1135.0 to 5721.0	11814 Titers Interval 1048.0 to 133124.0	3468 Titers Interval 492.0 to 24453.0	3103 Titers Interval 1914.0 to 5030.0	2994 Titers Interval 1577.0 to 5682.0	—
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 547	3548 Titers Interval 1599.0 to 7872.0	637 Titers Interval 327.0 to 1242.0	2149 Titers Interval 1119.0 to 4129.0	4613 Titers Interval 502.0 to 42401.0	2286 Titers Interval 865.0 to 6039.0	2359 Titers Interval 1077.0 to 5167.0	4080 Titers Interval 2732.0 to 6094.0	—

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758

RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=135 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=135 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 1	—	546 Titers Interval 487.0 to 612.0	552 Titers Interval 490.0 to 622.0	582 Titers Interval 460.0 to 738.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 15	—	6739 Titers Interval 5875.0 to 7730.0	4982 Titers Interval 4375.0 to 5673.0	525 Titers Interval 379.0 to 727.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 29	—	5808 Titers Interval 4981.0 to 6771.0	4338 Titers Interval 3767.0 to 4996.0	489 Titers Interval 394.0 to 607.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 57	—	4412 Titers Interval 3657.0 to 5322.0	3891 Titers Interval 3314.0 to 4568.0	563 Titers Interval 448.0 to 707.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 85	—	3765 Titers Interval 3220.0 to 4402.0	3252 Titers Interval 2829.0 to 3739.0	514 Titers Interval 399.0 to 661.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 183	—	3220 Titers Interval 2787.0 to 3721.0	2829 Titers Interval 2482.0 to 3225.0	673 Titers Interval 533.0 to 849.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 365	—	2021 Titers Interval 1706.0 to 2395.0	1895 Titers Interval 1641.0 to 2189.0	545 Titers Interval 413.0 to 720.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 393	—	2856 Titers Interval 2453.0 to 3325.0	1741 Titers Interval 1487.0 to 2038.0	585 Titers Interval 453.0 to 755.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 547	—	1743 Titers Interval 1484.0 to 2046.0	1364 Titers Interval 1160.0 to 1602.0	469 Titers Interval 353.0 to 622.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 730	—	1051 Titers Interval 866.0 to 1277.0	841 Titers Interval 710.0 to 997.0	314 Titers Interval 242.0 to 407.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 744	—	2116 Titers Interval 1790.0 to 2500.0	2473 Titers Interval 2004.0 to 3051.0	393 Titers Interval 280.0 to 552.0	—	—	—	—
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints Day 758	—	2201 Titers Interval 1852.0 to 2616.0	2315 Titers Interval 1783.0 to 3005.0	416 Titers Interval 293.0 to 589.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=34 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29	—	6053 Titers Interval 4770.0 to 7682.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 85

RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=34 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85	—	4616 Titers Interval 3395.0 to 6276.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547

Population: PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.

GMT (ELISA units per liter \[EU/L\]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 183	1095 EU/L Interval 512.0 to 2332.0	281 EU/L Interval 172.0 to 460.0	1045 EU/L Interval 379.0 to 2878.0	2105 EU/L Interval 1265.0 to 3502.0	1715 EU/L Interval 1023.0 to 2876.0	1415 EU/L Interval 803.0 to 2493.0	1654 EU/L Interval 998.0 to 2740.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 1	242 EU/L Interval 122.0 to 479.0	245 EU/L Interval 172.0 to 349.0	263 EU/L Interval 100.0 to 695.0	360 EU/L Interval 206.0 to 627.0	215 EU/L Interval 152.0 to 306.0	274 EU/L Interval 158.0 to 474.0	301 EU/L Interval 174.0 to 521.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 15	3396 EU/L Interval 1286.0 to 8971.0	261 EU/L Interval 171.0 to 398.0	2144 EU/L Interval 1026.0 to 4480.0	6121 EU/L Interval 3251.0 to 11528.0	4315 EU/L Interval 1277.0 to 14578.0	6268 EU/L Interval 4664.0 to 8424.0	3507 EU/L Interval 1854.0 to 6636.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 29	2257 EU/L Interval 1238.0 to 4115.0	219 EU/L Interval 150.0 to 319.0	1697 EU/L Interval 886.0 to 3252.0	4132 EU/L Interval 2515.0 to 6789.0	3352 EU/L Interval 1424.0 to 7889.0	3575 EU/L Interval 2955.0 to 4324.0	2396 EU/L Interval 1252.0 to 4583.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 57	2145 EU/L Interval 922.0 to 4986.0	246 EU/L Interval 166.0 to 363.0	1694 EU/L Interval 840.0 to 3417.0	4715 EU/L Interval 2526.0 to 8801.0	3450 EU/L Interval 1223.0 to 9733.0	3469 EU/L Interval 2218.0 to 5427.0	2339 EU/L Interval 1253.0 to 4366.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 85	1688 EU/L Interval 733.0 to 3887.0	268 EU/L Interval 176.0 to 408.0	2048 EU/L Interval 750.0 to 5592.0	3768 EU/L Interval 1843.0 to 7705.0	3996 EU/L Interval 1727.0 to 9247.0	3215 EU/L Interval 1998.0 to 5173.0	2672 EU/L Interval 1822.0 to 3918.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 365	928 EU/L Interval 444.0 to 1939.0	271 EU/L Interval 183.0 to 402.0	365 EU/L Interval 38.0 to 3500.0	1669 EU/L Interval 997.0 to 2792.0	993 EU/L Interval 571.0 to 1727.0	1192 EU/L Interval 679.0 to 2093.0	1415 EU/L Interval 836.0 to 2394.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 393	1952 EU/L Interval 940.0 to 4050.0	333 EU/L Interval 157.0 to 705.0	1259 EU/L Interval 606.0 to 2617.0	3523 EU/L Interval 2326.0 to 5337.0	2856 EU/L Interval 476.0 to 17148.0	2796 EU/L Interval 1425.0 to 5486.0	2970 EU/L Interval 1790.0 to 4929.0	—
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 547	1879 EU/L Interval 1041.0 to 3391.0	304 EU/L Interval 160.0 to 579.0	952 EU/L Interval 434.0 to 2086.0	2486 EU/L Interval 839.0 to 7364.0	1813 EU/L Interval 550.0 to 5975.0	1304 EU/L Interval 1075.0 to 1581.0	2241 EU/L Interval 1463.0 to 3433.0	—

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, and 547

GMT (ELISA units per liter \[EU/L\]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=42 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo n=24 Participants Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 1	326 EU/L Interval 256.0 to 416.0	436 EU/L Interval 321.0 to 591.0	354 EU/L Interval 278.0 to 452.0	278 EU/L Interval 227.0 to 342.0	274 EU/L Interval 206.0 to 365.0	318 EU/L Interval 264.0 to 382.0	314 EU/L Interval 239.0 to 413.0	229 EU/L Interval 172.0 to 304.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 15	5215 EU/L Interval 3984.0 to 6827.0	1239 EU/L Interval 970.0 to 1581.0	3860 EU/L Interval 3151.0 to 4728.0	3363 EU/L Interval 2662.0 to 4250.0	6055 EU/L Interval 4576.0 to 8012.0	5375 EU/L Interval 4225.0 to 6838.0	4925 EU/L Interval 3569.0 to 6796.0	217 EU/L Interval 160.0 to 297.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 183	1561 EU/L Interval 1183.0 to 2060.0	699 EU/L Interval 521.0 to 937.0	1086 EU/L Interval 874.0 to 1349.0	1121 EU/L Interval 902.0 to 1392.0	1369 EU/L Interval 1104.0 to 1689.0	1320 EU/L Interval 1108.0 to 1572.0	1083 EU/L Interval 848.0 to 1383.0	251 EU/L Interval 181.0 to 347.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 365	1230 EU/L Interval 946.0 to 1601.0	612 EU/L Interval 438.0 to 854.0	1027 EU/L Interval 831.0 to 1268.0	868 EU/L Interval 697.0 to 1081.0	990 EU/L Interval 796.0 to 1230.0	1105 EU/L Interval 934.0 to 1308.0	917 EU/L Interval 725.0 to 1160.0	204 EU/L Interval 131.0 to 317.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 29	3684 EU/L Interval 2884.0 to 4706.0	912 EU/L Interval 712.0 to 1167.0	2796 EU/L Interval 2335.0 to 3348.0	2435 EU/L Interval 1995.0 to 2973.0	3880 EU/L Interval 3044.0 to 4946.0	3610 EU/L Interval 2926.0 to 4454.0	3318 EU/L Interval 2545.0 to 4324.0	234 EU/L Interval 169.0 to 324.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 57	2903 EU/L Interval 2330.0 to 3618.0	1052 EU/L Interval 826.0 to 1342.0	2397 EU/L Interval 2016.0 to 2851.0	2150 EU/L Interval 1736.0 to 2664.0	2977 EU/L Interval 2429.0 to 3648.0	2853 EU/L Interval 2397.0 to 3394.0	2521 EU/L Interval 1981.0 to 3209.0	290 EU/L Interval 208.0 to 403.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 85	2686 EU/L Interval 2089.0 to 3455.0	1028 EU/L Interval 833.0 to 1270.0	2031 EU/L Interval 1691.0 to 2441.0	1824 EU/L Interval 1477.0 to 2252.0	2553 EU/L Interval 2087.0 to 3122.0	2400 EU/L Interval 2050.0 to 2811.0	1981 EU/L Interval 1480.0 to 2651.0	289 EU/L Interval 222.0 to 377.0
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 547	1072 EU/L Interval 861.0 to 1333.0	554 EU/L Interval 385.0 to 798.0	775 EU/L Interval 618.0 to 973.0	779 EU/L Interval 646.0 to 939.0	946 EU/L Interval 772.0 to 1160.0	937 EU/L Interval 797.0 to 1101.0	849 EU/L Interval 651.0 to 1106.0	264 EU/L Interval 168.0 to 414.0

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547

GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 15	973 EU/L Interval 424.0 to 2233.0	194 EU/L Interval 134.0 to 303.0	1208 EU/L Interval 476.0 to 3069.0	4841 EU/L Interval 2384.0 to 9831.0	2985 EU/L Interval 622.0 to 14323.0	3032 EU/L Interval 1699.0 to 5411.0	1739 EU/L Interval 632.0 to 4790.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 85	786 EU/L Interval 369.0 to 1672.0	220 EU/L Interval 141.0 to 342.0	1020 EU/L Interval 285.0 to 3650.0	2122 EU/L Interval 863.0 to 5214.0	1906 EU/L Interval 824.0 to 4409.0	1332 EU/L Interval 813.0 to 2184.0	1384 EU/L Interval 760.0 to 2520.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 183	547 EU/L Interval 289.0 to 1037.0	254 EU/L Interval 164.0 to 392.0	710 EU/L Interval 189.0 to 2671.0	1827 EU/L Interval 1059.0 to 3153.0	1163 EU/L Interval 650.0 to 2079.0	844 EU/L Interval 478.0 to 1492.0	857 EU/L Interval 425.0 to 1726.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 365	398 EU/L Interval 196.0 to 807.0	226 EU/L Interval 148.0 to 347.0	225 EU/L Interval 18.0 to 2874.0	1316 EU/L Interval 834.0 to 2075.0	657 EU/L Interval 288.0 to 1496.0	530 EU/L Interval 280.0 to 1002.0	740 EU/L Interval 401.0 to 1366.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 1	159 EU/L Interval 82.0 to 308.0	222 EU/L Interval 146.0 to 337.0	206 EU/L Interval 71.0 to 593.0	316 EU/L Interval 212.0 to 470.0	197 EU/L Interval 134.0 to 290.0	210 EU/L Interval 125.0 to 354.0	239 EU/L Interval 115.0 to 494.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 29	1033 EU/L Interval 607.0 to 1756.0	214 EU/L Interval 143.0 to 318.0	986 EU/L Interval 400.0 to 2432.0	3929 EU/L Interval 2197.0 to 7028.0	2303 EU/L Interval 891.0 to 5956.0	1698 EU/L Interval 1225.0 to 2353.0	1499 EU/L Interval 712.0 to 3156.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 57	693 EU/L Interval 343.0 to 1400.0	217 EU/L Interval 145.0 to 325.0	1164 EU/L Interval 303.0 to 4473.0	3098 EU/L Interval 1730.0 to 5550.0	964 EU/L Interval 280.0 to 3321.0	864 EU/L Interval 337.0 to 2216.0	866 EU/L Interval 355.0 to 2113.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 393	1140 EU/L Interval 590.0 to 2199.0	237 EU/L Interval 106.0 to 530.0	874 EU/L Interval 293.0 to 2609.0	2385 EU/L Interval 1637.0 to 3476.0	1631 EU/L Interval 206.0 to 12930.0	1408 EU/L Interval 458.0 to 4333.0	1330 EU/L Interval 497.0 to 3558.0	—
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 547	792 EU/L Interval 447.0 to 1403.0	243 EU/L Interval 114.0 to 516.0	607 EU/L Interval 178.0 to 2071.0	1382 EU/L Interval 1018.0 to 1877.0	863 EU/L Interval 254.0 to 2936.0	723 EU/L Interval 428.0 to 1221.0	1001 EU/L Interval 550.0 to 1823.0	—

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, and 547

GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=42 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=42 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=42 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo n=24 Participants Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 85	1504 EU/L Interval 1096.0 to 2065.0	513 EU/L Interval 339.0 to 775.0	1144 EU/L Interval 937.0 to 1398.0	1050 EU/L Interval 825.0 to 1337.0	1397 EU/L Interval 1061.0 to 1839.0	1400 EU/L Interval 1064.0 to 1834.0	1088 EU/L Interval 817.0 to 1450.0	241 EU/L Interval 171.0 to 340.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 365	755 EU/L Interval 547.0 to 1041.0	409 EU/L Interval 261.0 to 642.0	666 EU/L Interval 537.0 to 825.0	605 EU/L Interval 478.0 to 765.0	652 EU/L Interval 501.0 to 847.0	785 EU/L Interval 607.0 to 1015.0	660 EU/L Interval 521.0 to 836.0	166 EU/L Interval 97.0 to 281.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 1	234 EU/L Interval 172.0 to 318.0	270 EU/L Interval 185.0 to 393.0	260 EU/L Interval 204.0 to 332.0	228 EU/L Interval 184.0 to 284.0	202 EU/L Interval 146.0 to 278.0	237 EU/L Interval 189.0 to 289.0	246 EU/L Interval 188.0 to 323.0	190 EU/L Interval 135.0 to 267.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 15	2365 EU/L Interval 1640.0 to 3410.0	679 EU/L Interval 509.0 to 906.0	1785 EU/L Interval 1415.0 to 2251.0	1555 EU/L Interval 1185.0 to 2040.0	2524 EU/L Interval 1764.0 to 3611.0	2617 EU/L Interval 1921.0 to 3564.0	2159 EU/L Interval 1545.0 to 3015.0	181 EU/L Interval 130.0 to 254.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 29	1994 EU/L Interval 1436.0 to 2769.0	612 EU/L Interval 467.0 to 802.0	1542 EU/L Interval 1233.0 to 1929.0	1233 EU/L Interval 856.0 to 1775.0	2195 EU/L Interval 1607.0 to 2999.0	2203 EU/L Interval 1655.0 to 2933.0	1863 EU/L Interval 1419.0 to 2444.0	219 EU/L Interval 145.0 to 331.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 57	1661 EU/L Interval 1212.0 to 2277.0	634 EU/L Interval 479.0 to 863.0	1403 EU/L Interval 1162.0 to 1693.0	1239 EU/L Interval 960.0 to 1598.0	1754 EU/L Interval 1318.0 to 2333.0	1740 EU/L Interval 1339.0 to 2262.0	1506 EU/L Interval 1178.0 to 1929.0	257 EU/L Interval 177.0 to 372.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 183	924 EU/L Interval 658.0 to 1297.0	455 EU/L Interval 324.0 to 639.0	735 EU/L Interval 583.0 to 926.0	727 EU/L Interval 581.0 to 909.0	896 EU/L Interval 667.0 to 1130.0	908 EU/L Interval 716.0 to 1151.0	709 EU/L Interval 565.0 to 889.0	232 EU/L Interval 167.0 to 323.0
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints Day 547	720 EU/L Interval 543.0 to 956.0	381 EU/L Interval 234.0 to 621.0	507 EU/L Interval 394.0 to 652.0	556 EU/L Interval 445.0 to 693.0	640 EU/L Interval 477.0 to 859.0	741 EU/L Interval 562.0 to 977.0	570 EU/L Interval 449.0 to 723.0	222 EU/L Interval 141.0 to 349.0

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547

Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was Spot forming units (SFU)/10\^6 peripheral blood mononuclear cells (PBMCs).

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=16 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=8 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=8 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 29	416 SFU/10^6 PBMCs Interval 219.0 to 1910.0	46 SFU/10^6 PBMCs Interval 1.0 to 193.0	211 SFU/10^6 PBMCs Interval 123.0 to 1190.0	183 SFU/10^6 PBMCs Interval 124.0 to 825.0	153 SFU/10^6 PBMCs Interval 20.0 to 380.0	271 SFU/10^6 PBMCs Interval 207.0 to 368.0	271 SFU/10^6 PBMCs Interval 110.0 to 397.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 57	315 SFU/10^6 PBMCs Interval 143.0 to 2635.0	42 SFU/10^6 PBMCs Interval 8.0 to 225.0	78 SFU/10^6 PBMCs Interval 45.0 to 114.0	180 SFU/10^6 PBMCs Interval 32.0 to 491.0	130 SFU/10^6 PBMCs Interval 41.0 to 343.0	244 SFU/10^6 PBMCs Interval 121.0 to 461.0	167 SFU/10^6 PBMCs Interval 14.0 to 290.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 85	274 SFU/10^6 PBMCs Interval 181.0 to 3123.0	52 SFU/10^6 PBMCs Interval 1.0 to 323.0	199 SFU/10^6 PBMCs Interval 169.0 to 482.0	398 SFU/10^6 PBMCs Interval 137.0 to 622.0	293 SFU/10^6 PBMCs Interval 131.0 to 590.0	556 SFU/10^6 PBMCs Interval 355.0 to 1229.0	432 SFU/10^6 PBMCs Interval 158.0 to 663.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 183	215 SFU/10^6 PBMCs Interval 62.0 to 3022.0	56 SFU/10^6 PBMCs Interval 1.0 to 629.0	105 SFU/10^6 PBMCs Interval 33.0 to 386.0	281 SFU/10^6 PBMCs Interval 148.0 to 599.0	172 SFU/10^6 PBMCs Interval 74.0 to 271.0	301 SFU/10^6 PBMCs Interval 115.0 to 531.0	305 SFU/10^6 PBMCs Interval 144.0 to 472.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 365	249 SFU/10^6 PBMCs Interval 117.0 to 2021.0	61 SFU/10^6 PBMCs Interval 21.0 to 312.0	152 SFU/10^6 PBMCs Interval 54.0 to 309.0	270 SFU/10^6 PBMCs Interval 171.0 to 582.0	158 SFU/10^6 PBMCs Interval 107.0 to 442.0	297 SFU/10^6 PBMCs Interval 128.0 to 531.0	231 SFU/10^6 PBMCs Interval 136.0 to 594.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 393	443 SFU/10^6 PBMCs Interval 248.0 to 2362.0	54 SFU/10^6 PBMCs Interval 3.0 to 411.0	159 SFU/10^6 PBMCs Interval 93.0 to 584.0	492 SFU/10^6 PBMCs Interval 321.0 to 811.0	472 SFU/10^6 PBMCs Interval 211.0 to 733.0	720 SFU/10^6 PBMCs Interval 614.0 to 1000.0	400 SFU/10^6 PBMCs Interval 25.0 to 726.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 547	258 SFU/10^6 PBMCs Interval 96.0 to 2443.0	42 SFU/10^6 PBMCs Interval 11.0 to 737.0	199 SFU/10^6 PBMCs Interval 67.0 to 306.0	262 SFU/10^6 PBMCs Interval 197.0 to 397.0	245 SFU/10^6 PBMCs Interval 107.0 to 308.0	374 SFU/10^6 PBMCs Interval 195.0 to 387.0	202 SFU/10^6 PBMCs Interval 85.0 to 505.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 1	56 SFU/10^6 PBMCs Interval 16.0 to 175.0	48 SFU/10^6 PBMCs Interval 6.0 to 254.0	39 SFU/10^6 PBMCs Interval 13.0 to 103.0	16 SFU/10^6 PBMCs Interval 5.0 to 121.0	26 SFU/10^6 PBMCs Interval 2.0 to 91.0	71 SFU/10^6 PBMCs Interval 12.0 to 182.0	34 SFU/10^6 PBMCs Interval 1.0 to 57.0	—
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 15	480 SFU/10^6 PBMCs Interval 53.0 to 2696.0	57 SFU/10^6 PBMCs Interval 10.0 to 286.0	341 SFU/10^6 PBMCs Interval 79.0 to 562.0	432 SFU/10^6 PBMCs Interval 102.0 to 1004.0	316 SFU/10^6 PBMCs Interval 177.0 to 876.0	390 SFU/10^6 PBMCs Interval 142.0 to 531.0	399 SFU/10^6 PBMCs Interval 158.0 to 631.0	—

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758

Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was SFU/10\^6 PBMCs.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=25 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=26 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=9 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 547	—	284 SFU/10^6 PBMCs Interval 94.0 to 6756.0	233 SFU/10^6 PBMCs Interval 37.0 to 2108.0	17 SFU/10^6 PBMCs Interval 1.0 to 166.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 730	—	210 SFU/10^6 PBMCs Interval 103.0 to 5930.0	243 SFU/10^6 PBMCs Interval 41.0 to 1873.0	25 SFU/10^6 PBMCs Interval 14.0 to 64.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 744	—	707 SFU/10^6 PBMCs Interval 213.0 to 5975.0	651 SFU/10^6 PBMCs Interval 390.0 to 1607.0	35 SFU/10^6 PBMCs Interval 6.0 to 65.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 758	—	390 SFU/10^6 PBMCs Interval 84.0 to 5290.0	430 SFU/10^6 PBMCs Interval 264.0 to 2326.0	14 SFU/10^6 PBMCs Interval 1.0 to 25.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 15	—	515 SFU/10^6 PBMCs Interval 128.0 to 2308.0	566 SFU/10^6 PBMCs Interval 153.0 to 1563.0	17 SFU/10^6 PBMCs Interval 2.0 to 258.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 29	—	348 SFU/10^6 PBMCs Interval 10.0 to 3179.0	457 SFU/10^6 PBMCs Interval 162.0 to 1089.0	46 SFU/10^6 PBMCs Interval 1.0 to 294.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 57	—	371 SFU/10^6 PBMCs Interval 122.0 to 3614.0	424 SFU/10^6 PBMCs Interval 181.0 to 2910.0	41 SFU/10^6 PBMCs Interval 2.0 to 264.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 85	—	301 SFU/10^6 PBMCs Interval 103.0 to 3770.0	327 SFU/10^6 PBMCs Interval 58.0 to 3187.0	18 SFU/10^6 PBMCs Interval 18.0 to 499.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 183	—	218 SFU/10^6 PBMCs Interval 60.0 to 3710.0	227 SFU/10^6 PBMCs Interval 18.0 to 3186.0	32 SFU/10^6 PBMCs Interval 7.0 to 211.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 365	—	152 SFU/10^6 PBMCs Interval 40.0 to 3261.0	233 SFU/10^6 PBMCs Interval 61.0 to 2896.0	44 SFU/10^6 PBMCs Interval 1.0 to 123.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 393	—	364 SFU/10^6 PBMCs Interval 92.0 to 994.0	207 SFU/10^6 PBMCs Interval 41.0 to 2634.0	30 SFU/10^6 PBMCs Interval 2.0 to 211.0	—	—	—	—
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints Day 1	—	56 SFU/10^6 PBMCs Interval 5.0 to 612.0	73 SFU/10^6 PBMCs Interval 1.0 to 1030.0	39 SFU/10^6 PBMCs Interval 1.0 to 193.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 29

Population: The PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=18 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=33 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=33 Participants Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg n=35 Participants Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=34 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=31 Participants Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29	—	320 SFU/10^6 PBMCs Interval 203.0 to 592.0	354 SFU/10^6 PBMCs Interval 227.0 to 453.0	315 SFU/10^6 PBMCs Interval 192.0 to 497.0	290 SFU/10^6 PBMCs Interval 187.0 to 485.0	390 SFU/10^6 PBMCs Interval 251.0 to 586.0	298 SFU/10^6 PBMCs Interval 195.0 to 374.0	—

SECONDARY outcome

Timeframe: Day 85

Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=28 Participants Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.	Cohort 1: RSV preF Protein 150 mcg Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 2: Pooled Placebo Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85	—	495 SFU/10^6 PBMCs Interval 113.0 to 6855.0	—	—	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Pooled Placebo n=16 participants at risk Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.	Cohort 1: RSV preF Protein 50 mcg n=8 participants at risk Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 50 mcg (Mixture) n=8 participants at risk Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5\10\^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.	Cohort 1: RSV preF Protein 150 mcg n=8 participants at risk Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 participants at risk Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 participants at risk Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2:Ad26.RSV.preF 510^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.	Cohort 2:Ad26.RSV.preF 110^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 participants at risk Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.	Cohort 2: Pooled Placebo n=24 participants at risk Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) n=135 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo n=136 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 participants at risk Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Gastrointestinal disorders Gastritis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Hiatus Hernia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Melaena	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Adverse Drug Reaction	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Chest Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Death	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Influenza Like Illness	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Angina Pectoris	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Arrhythmia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Atrial Fibrillation	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Cardiac Arrest	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Coronary Artery Disease	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Cardiac disorders Myocardial Infarction	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Congenital, familial and genetic disorders Atrial Septal Defect	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Hepatobiliary disorders Cholelithiasis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Hepatobiliary disorders Portal Vein Thrombosis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Appendicitis Perforated	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Arthritis Infective	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Bacteraemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Bacterial Sepsis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Cellulitis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Covid-19	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Diverticulitis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Liver Abscess	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Pneumonia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Pyelonephritis Acute	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Fall	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Investigations Heart Rate Irregular	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Stage I	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Palate Neoplasm	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Carotid Artery Occlusion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Carotid Artery Stenosis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Cerebrovascular Accident	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Chronic Inflammatory Demyelinating Polyradiculoneuropathy	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Lacunar Infarction	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Paraesthesia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Subarachnoid Haemorrhage	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Syncope	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Psychiatric disorders Anxiety	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Psychiatric disorders Mental Status Changes	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Psychiatric disorders Substance Abuse	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Aortic Aneurysm	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Arteriosclerosis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Distributive Shock	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Haemodynamic Instability	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Hypertension	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Thrombosis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.

Other adverse events

Other adverse events
Measure	Cohort 1: Pooled Placebo n=16 participants at risk Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.	Cohort 1: RSV preF Protein 50 mcg n=8 participants at risk Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 50 mcg (Mixture) n=8 participants at risk Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5\10\^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.	Cohort 1: RSV preF Protein 150 mcg n=8 participants at risk Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.	Cohort 1: Ad26.RSV.preF 510^10 vp + RSV preF Protein 150 mcg (Mixture) n=8 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=8 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.	Cohort 1: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=8 participants at risk Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.	Cohort 2: Ad26.RSV.preF 110^11 vp With Placebo and Placebo Alone n=24 participants at risk Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.	Cohort 2:Ad26.RSV.preF 510^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.	Cohort 2:Ad26.RSV.preF 110^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.	Cohort 2: Ad26.RSV.preF 510^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone n=42 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 5\10\^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp With RSV preF Protein 150 mcg and Placebo Alone n=36 participants at risk Participants received a single IM injection of Ad26.RSV.preF 1\10\^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.	Cohort 2: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo n=36 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.	Cohort 2: Pooled Placebo n=24 participants at risk Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) n=135 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.	Cohort 3: Ad26.RSV.preF 110^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo n=136 participants at risk Participants received a single IM injection of a mixture of Ad26.RSV.preF 1\10\^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.	Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen n=44 participants at risk Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Ear and labyrinth disorders Ear Congestion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Ear and labyrinth disorders Vertigo	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Eye disorders Cataract	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Eye disorders Eye Irritation	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Eye disorders Eye Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Eye disorders Glaucoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Eye disorders Trichiasis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Constipation	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Enteritis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Leukoplakia Oral	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Nausea	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Salivary Gland Enlargement	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Swollen Tongue	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Gastrointestinal disorders Vomiting	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Injection Site Erosion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Injection Site Haematoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Injection Site Haemorrhage	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Injection Site Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.8% 2/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Injection Site Swelling	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Oedema Peripheral	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
General disorders Thirst	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Immune system disorders Allergy to Arthropod Bite	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Immune system disorders Drug Hypersensitivity	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Immune system disorders Hypersensitivity	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Bronchitis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Conjunctivitis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Folliculitis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Fungal Infection	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Herpes Zoster	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Hordeolum	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Oral Herpes	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Otitis Externa	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Respiratory Tract Infection	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	16.7% 4/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	19.0% 8/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	9.5% 4/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	11.9% 5/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	8.3% 3/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	13.9% 5/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	20.8% 5/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.2% 3/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.2% 3/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Sinusitis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Tooth Abscess	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Tooth Infection	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Infections and infestations Urinary Tract Infection	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Animal Scratch	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Concussion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Corneal Abrasion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Investigations Blood Pressure Diastolic Increased	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Investigations Blood Pressure Increased	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Investigations Blood Pressure Systolic Increased	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Investigations Haemoglobin Decreased	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.8% 2/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.8% 2/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	8.3% 3/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.8% 2/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.8% 2/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Musculoskeletal and connective tissue disorders Synovial Cyst	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic Keratosis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Head and Neck	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Balance Disorder	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Dizziness	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Dizziness Postural	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Headache	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Migraine	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Paraesthesia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Presyncope	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Nervous system disorders Syncope	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Psychiatric disorders Anxiety	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Psychiatric disorders Depression	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Psychiatric disorders Insomnia	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	1.5% 2/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Nasal Pruritus	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	12.5% 1/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Skin and subcutaneous tissue disorders Eczema	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.74% 1/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.8% 1/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Haematoma	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Hypertension	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.2% 1/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	4.4% 6/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.9% 4/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.3% 1/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Peripheral Arterial Occlusive Disease	6.2% 1/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Vascular disorders Peripheral Venous Disease	0.00% 0/16 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/8 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	2.4% 1/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/42 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/36 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/24 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/135 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/136 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.	0.00% 0/44 • From Day 1 up to 1095 days The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.

Additional Information

Clinical Franchise Leader

Janssen Vaccines & Prevention B.V.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER