Trial Outcomes & Findings for Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years) (NCT NCT00973700)

Last Updated: 2015-12-02

Results Overview

Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

784 participants

Primary outcome timeframe

Day 1 to day 387

Results posted on

2015-12-02

Participant Flow

Participants were enrolled at one center in Costa Rica.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	2x7.5adj A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_8 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8	7.5adj_1_22 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Study STARTED	56	56	168	336	168
Overall Study COMPLETED	49	54	158	318	158
Overall Study NOT COMPLETED	7	2	10	18	10

Reasons for withdrawal

Reasons for withdrawal
Measure	2x7.5adj A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_8 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8	7.5adj_1_22 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Study Withdrawal by Subject	2	2	8	4	4
Overall Study Lost to Follow-up	5	0	1	8	5
Overall Study Inappropriate enrolment	0	0	0	4	0
Overall Study Unable to Classify	0	0	1	2	1

Baseline Characteristics

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2x7.5adj n=56 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_8 n=56 Participants A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8	7.5adj_1_22 n=168 Participants A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 n=336 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 n=168 Participants A/H1N1 15 mcg no MF59; two doses on days 1 and 22	Total n=784 Participants Total of all reporting groups
Age, Customized 3 to < 9 years	0 subjects 0 • n=5 Participants	0 subjects 0 • n=7 Participants	56 subjects 1.7 • n=5 Participants	84 subjects 1.7 • n=4 Participants	56 subjects 1.9 • n=21 Participants	196 subjects n=10 Participants
Age, Customized 9 to 17 years	0 subjects 0 • n=5 Participants	0 subjects 0 • n=7 Participants	56 subjects 2.5 • n=5 Participants	84 subjects 2.3 • n=4 Participants	56 subjects 2.5 • n=21 Participants	196 subjects n=10 Participants
Age, Customized 18 to 64 years	56 subjects 10.8 • n=5 Participants	56 subjects 11.1 • n=7 Participants	56 subjects 11.2 • n=5 Participants	168 subjects 11.7 • n=4 Participants	56 subjects 11.0 • n=21 Participants	392 subjects n=10 Participants
Sex/Gender, Customized Female (3 to <9 years)	0 Subjects n=5 Participants	0 Subjects n=7 Participants	29 Subjects n=5 Participants	46 Subjects n=4 Participants	23 Subjects n=21 Participants	98 Subjects n=10 Participants
Sex/Gender, Customized Male (3 to < 9 years)	0 Subjects n=5 Participants	0 Subjects n=7 Participants	27 Subjects n=5 Participants	38 Subjects n=4 Participants	33 Subjects n=21 Participants	98 Subjects n=10 Participants
Sex/Gender, Customized Female (9 to 17 years)	0 Subjects n=5 Participants	0 Subjects n=7 Participants	40 Subjects n=5 Participants	40 Subjects n=4 Participants	30 Subjects n=21 Participants	110 Subjects n=10 Participants
Sex/Gender, Customized Male (9 to 17 years)	0 Subjects n=5 Participants	0 Subjects n=7 Participants	16 Subjects n=5 Participants	44 Subjects n=4 Participants	26 Subjects n=21 Participants	86 Subjects n=10 Participants
Sex/Gender, Customized Female (18 to 64 years)	33 Subjects n=5 Participants	40 Subjects n=7 Participants	29 Subjects n=5 Participants	96 Subjects n=4 Participants	29 Subjects n=21 Participants	227 Subjects n=10 Participants
Sex/Gender, Customized Male (18 to 64 years)	23 Subjects n=5 Participants	16 Subjects n=7 Participants	27 Subjects n=5 Participants	72 Subjects n=4 Participants	27 Subjects n=21 Participants	165 Subjects n=10 Participants

PRIMARY outcome

Timeframe: Day 1 to day 387

Population: The analysis was done on the per-protocol set.

Outcome measures

Outcome measures
Measure	15_1_22 n=149 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age HI Titer ≥40 on day 1	26 Percentages of Subjects Interval 19.0 to 33.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age HI Titer ≥40 on day 22	83 Percentages of Subjects Interval 76.0 to 89.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age HI Titer ≥40 on day 29	95 Percentages of Subjects Interval 91.0 to 98.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age HI Titer ≥40 on day 43	92 Percentages of Subjects Interval 86.0 to 96.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age HI Titer ≥40 on day 217 (N=129)	88 Percentages of Subjects Interval 81.0 to 93.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age HI Titer ≥40 on day 387 (N=136)	80 Percentages of Subjects Interval 72.0 to 86.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age Seroconversion on day 22	79 Percentages of Subjects Interval 71.0 to 85.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age Seroconversion on day 29	92 Percentages of Subjects Interval 86.0 to 96.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age Seroconversion on day 43	87 Percentages of Subjects Interval 81.0 to 92.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age Seroconversion on day 217 (N=129)	71 Percentages of Subjects Interval 62.0 to 78.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age Seroconversion on day 387 (N=136)	63 Percentages of Subjects Interval 54.0 to 71.0	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 to day 387

Population: The analysis was done on the per-protocol set.

Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).

Outcome measures

Outcome measures
Measure	15_1_22 n=132 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on day 1	18 Percentages of Subjects Interval 12.0 to 26.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on day 8	93 Percentages of Subjects Interval 87.0 to 97.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on day 15	99 Percentages of Subjects Interval 96.0 to 100.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on day 22	98 Percentages of Subjects Interval 95.0 to 100.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on day 29	99 Percentages of Subjects Interval 96.0 to 100.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on Day 43	100 Percentages of Subjects Interval 97.0 to 100.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on Day 217 (N=111)	91 Percentages of Subjects Interval 84.0 to 96.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age HI Titer ≥40 on Day 387 (N=120)	84 Percentages of Subjects Interval 76.0 to 90.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 8	86 Percentages of Subjects Interval 78.0 to 91.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 15	94 Percentages of Subjects Interval 88.0 to 97.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 22	94 Percentages of Subjects Interval 88.0 to 97.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 29	95 Percentages of Subjects Interval 90.0 to 98.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 43	95 Percentages of Subjects Interval 90.0 to 98.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 217 (N=111)	81 Percentages of Subjects Interval 73.0 to 88.0	—	—	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age Seroconversion on day 387 (N=120)	75 Percentages of Subjects Interval 66.0 to 82.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline

Population: The overall number of baseline participants.

Outcome measures

Outcome measures
Measure	15_1_22 n=56 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=56 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=168 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 n=336 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 n=168 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1
Age Distribution at Baseline 3 to <9 years (N=0, 0, 56, 84, 56)	NA years Standard Deviation NA Not Applicable (NA) as 0 subjects were in this category.	NA years Standard Deviation NA Not Applicable (NA) as 0 subjects were in this category.	5.5 years Standard Deviation 1.7	5.7 years Standard Deviation 1.7	5.4 years Standard Deviation 1.9
Age Distribution at Baseline 9 to 17 years (N=0, 0, 56, 84, 56)	NA years Standard Deviation NA Not Applicable (NA) as 0 subjects were in this category.	NA years Standard Deviation NA Not Applicable (NA) as 0 subjects were in this category.	13.1 years Standard Deviation 2.5	12.8 years Standard Deviation 2.3	13.1 years Standard Deviation 2.5
Age Distribution at Baseline 18 to 64 years (N= 56, 56, 56, 168, 56)	35.1 years Standard Deviation 10.8	38.6 years Standard Deviation 11.1	37.3 years Standard Deviation 11.2	37.0 years Standard Deviation 11.7	37.4 years Standard Deviation 11.0

SECONDARY outcome

Timeframe: Day 1 to day 387

Population: The analysis is done on the per-protocol set.

Outcome measures

Outcome measures
Measure	15_1_22 n=91 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=149 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=99 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 22 (3 to <9 yrs; N=46,75,47)	91 Percentages of Subjects Interval 79.0 to 98.0	69 Percentages of Subjects Interval 58.0 to 79.0	79 Percentages of Subjects Interval 64.0 to 89.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 29 (3 to <9 yrs; N=46,75,47)	98 Percentages of Subjects Interval 88.0 to 100.0	92 Percentages of Subjects Interval 83.0 to 97.0	96 Percentages of Subjects Interval 85.0 to 99.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 43 (3 to <9 yrs; N=46,75,47)	96 Percentages of Subjects Interval 85.0 to 99.0	84 Percentages of Subjects Interval 74.0 to 91.0	94 Percentages of Subjects Interval 82.0 to 99.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 217 (3 to <9 yrs;N=41,66,40)	88 Percentages of Subjects Interval 74.0 to 96.0	65 Percentages of Subjects Interval 52.0 to 76.0	65 Percentages of Subjects Interval 48.0 to 79.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 387 (3 to <9 yrs;N=43,70,42)	77 Percentages of Subjects Interval 61.0 to 88.0	56 Percentages of Subjects Interval 43.0 to 68.0	50 Percentages of Subjects Interval 34.0 to 66.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 1 (9 to 17 yrs;N=45,74,52)	42 Percentages of Subjects Interval 28.0 to 58.0	28 Percentages of Subjects Interval 19.0 to 40.0	33 Percentages of Subjects Interval 20.0 to 47.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 22 (9 to 17 yrs; N=45,74,52)	98 Percentages of Subjects Interval 88.0 to 100.0	96 Percentages of Subjects Interval 89.0 to 99.0	100 Percentages of Subjects Interval 93.0 to 100.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 29 (9 to 17 yrs; N=45,74,52)	100 Percentages of Subjects Interval 92.0 to 100.0	99 Percentages of Subjects Interval 93.0 to 100.0	100 Percentages of Subjects Interval 93.0 to 100.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 43 (9 to 17 yrs; N=45,74,52)	100 Percentages of Subjects Interval 92.0 to 100.0	99 Percentages of Subjects Interval 93.0 to 100.0	100 Percentages of Subjects Interval 93.0 to 100.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 217 (9 to 17 yrs; N=37,63,45)	100 Percentages of Subjects Interval 91.0 to 100.0	95 Percentages of Subjects Interval 87.0 to 99.0	98 Percentages of Subjects Interval 88.0 to 100.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 387 (9 to 17 yrs; N=37,66,47)	89 Percentages of Subjects Interval 75.0 to 97.0	88 Percentages of Subjects Interval 78.0 to 95.0	89 Percentages of Subjects Interval 77.0 to 96.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 22 (9 to 17 yrs; N=45,74,52)	87 Percentages of Subjects Interval 73.0 to 95.0	88 Percentages of Subjects Interval 78.0 to 94.0	94 Percentages of Subjects Interval 84.0 to 99.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 29 (9 to 17 yrs; N=45,74,52)	89 Percentages of Subjects Interval 76.0 to 96.0	92 Percentages of Subjects Interval 83.0 to 97.0	94 Percentages of Subjects Interval 84.0 to 99.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 43 (9 to 17 yrs; N=45,74,52)	84 Percentages of Subjects Interval 71.0 to 94.0	91 Percentages of Subjects Interval 81.0 to 96.0	92 Percentages of Subjects Interval 81.0 to 98.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 217 (9 to 17 yrs;N=37,63,45)	68 Percentages of Subjects Interval 50.0 to 82.0	76 Percentages of Subjects Interval 64.0 to 86.0	76 Percentages of Subjects Interval 60.0 to 87.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years Seroconversion on day 387 (9 to 17 yrs;N=37,66,47)	59 Percentages of Subjects Interval 42.0 to 75.0	70 Percentages of Subjects Interval 57.0 to 80.0	70 Percentages of Subjects Interval 55.0 to 83.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 1 (3 to <9 yrs; N=46,75,47)	24 Percentages of Subjects Interval 13.0 to 39.0	23 Percentages of Subjects Interval 14.0 to 34.0	23 Percentages of Subjects Interval 12.0 to 38.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 22 (3 to <9 yrs; N=46,75,47)	93 Percentages of Subjects Interval 82.0 to 99.0	71 Percentages of Subjects Interval 59.0 to 81.0	79 Percentages of Subjects Interval 64.0 to 89.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 29 (3 to < 9 yrs; N=46,75,47)	100 Percentages of Subjects Interval 92.0 to 100.0	92 Percentages of Subjects Interval 83.0 to 97.0	96 Percentages of Subjects Interval 85.0 to 99.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 43 (3 to < 9 yrs; N=46,75,47)	100 Percentages of Subjects Interval 92.0 to 100.0	85 Percentages of Subjects Interval 75.0 to 92.0	96 Percentages of Subjects Interval 85.0 to 99.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 217 (3 to < 9 yrs; N=41,66,40)	100 Percentages of Subjects Interval 91.0 to 100.0	80 Percentages of Subjects Interval 69.0 to 89.0	78 Percentages of Subjects Interval 62.0 to 89.0	—	—
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years HI Titer ≥40 on day 387 (3 to < 9 yrs; N=43,70,42)	93 Percentages of Subjects Interval 81.0 to 99.0	73 Percentages of Subjects Interval 61.0 to 83.0	62 Percentages of Subjects Interval 46.0 to 76.0	—	—

SECONDARY outcome

Timeframe: Day 1 to day 387

Population: The analysis is done on the per-protocol set.

Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).

Outcome measures

Outcome measures
Measure	15_1_22 n=91 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=149 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=99 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 22 (3 to < 9 yrs; N=46,75,47)	31 Ratio Interval 19.0 to 50.0	12 Ratio Interval 8.51 to 18.0	16 Ratio Interval 10.0 to 26.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 29 (3 to < 9 yrs; N=46,75,47)	169 Ratio Interval 110.0 to 260.0	35 Ratio Interval 24.0 to 49.0	53 Ratio Interval 35.0 to 82.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 43 (3 to < 9 yrs; N=46,75,47)	120 Ratio Interval 75.0 to 192.0	22 Ratio Interval 15.0 to 32.0	44 Ratio Interval 27.0 to 69.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 217 (3 to <9 yrs; N=41,66,40)	19 Ratio Interval 12.0 to 30.0	7.79 Ratio Interval 5.46 to 11.0	8.07 Ratio Interval 5.11 to 13.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 387 (3 to <9 yrs; N=43,70,42)	14 Ratio Interval 8.27 to 24.0	6.9 Ratio Interval 4.58 to 10.0	5.94 Ratio Interval 3.5 to 10.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 22 (9 to 17 yrs; N=45,74,52)	42 Ratio Interval 24.0 to 74.0	52 Ratio Interval 34.0 to 81.0	66 Ratio Interval 39.0 to 111.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 29 (9 to 17 yrs; N=45,74,52)	63 Ratio Interval 36.0 to 109.0	70 Ratio Interval 45.0 to 108.0	79 Ratio Interval 47.0 to 132.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 43 (9 to 17 yrs; N=45,74,52)	44 Ratio Interval 25.0 to 77.0	48 Ratio Interval 31.0 to 75.0	59 Ratio Interval 35.0 to 100.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 217 (9 to 17 yrs; N=37,63,45)	10 Ratio Interval 5.66 to 18.0	17 Ratio Interval 11.0 to 26.0	13 Ratio Interval 7.92 to 23.0	—	—
HI GMRs, in 3 to <9 Years and 9 to 17 Years GMR on day 387 (9 to 17 yrs; N=37,66,47)	7.22 Ratio Interval 3.77 to 14.0	16 Ratio Interval 9.53 to 25.0	13 Ratio Interval 7.53 to 24.0	—	—

SECONDARY outcome

Timeframe: Day 1 to day 387

Population: The analysis is done on the per-protocol set.

Outcome measures

Outcome measures
Measure	15_1_22 n=41 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=45 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=45 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 n=132 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 n=47 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1
HI GMR, in Adults 18 to 64 Years GMR on day 8	48 Ratio Interval 28.0 to 85.0	35 Ratio Interval 21.0 to 60.0	57 Ratio Interval 33.0 to 97.0	43 Ratio Interval 32.0 to 59.0	63 Ratio Interval 37.0 to 106.0
HI GMR, in Adults 18 to 64 Years GMR on day 15	115 Ratio Interval 70.0 to 189.0	181 Ratio Interval 113.0 to 292.0	200 Ratio Interval 124.0 to 322.0	138 Ratio Interval 104.0 to 182.0	123 Ratio Interval 77.0 to 197.0
HI GMR, in Adults 18 to 64 Years GMR on day 22	79 Ratio Interval 48.0 to 130.0	100 Ratio Interval 63.0 to 160.0	123 Ratio Interval 77.0 to 197.0	85 Ratio Interval 64.0 to 111.0	72 Ratio Interval 45.0 to 113.0
HI GMR, in Adults 18 to 64 Years GMR on day 29	56 Ratio Interval 35.0 to 89.0	76 Ratio Interval 49.0 to 118.0	160 Ratio Interval 103.0 to 248.0	83 Ratio Interval 64.0 to 107.0	66 Ratio Interval 43.0 to 101.0
HI GMR, in Adults 18 to 64 Years GMR on day 43	44 Ratio Interval 27.0 to 71.0	64 Ratio Interval 40.0 to 101.0	101 Ratio Interval 63.0 to 161.0	76 Ratio Interval 58.0 to 100.0	65 Ratio Interval 41.0 to 102.0
HI GMR, in Adults 18 to 64 Years GMR on day (N=0,0,35,111,34)	NA Ratio Zero subjects were enrolled in this group.	NA Ratio Zero subjects were enrolled in this group.	30 Ratio Interval 18.0 to 48.0	16 Ratio Interval 12.0 to 20.0	16 Ratio Interval 10.0 to 27.0
HI GMR, in Adults 18 to 64 Years GMR on day 387 (N=38,40,38,120,42)	6.61 Ratio Interval 3.92 to 11.0	11 Ratio Interval 6.81 to 19.0	21 Ratio Interval 12.0 to 36.0	12 Ratio Interval 8.99 to 16.0	9.21 Ratio Interval 5.61 to 15.0

SECONDARY outcome

Timeframe: 7 days and 21 days after each vaccination

Population: The analysis is done on the per-protocol set.

Outcome measures

Outcome measures
Measure	15_1_22 n=41 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=45 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=45 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 n=132 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 n=47 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 8	100 Percentages of Subjects Interval 91.0 to 100.0	91 Percentages of Subjects Interval 79.0 to 98.0	96 Percentages of Subjects Interval 85.0 to 99.0	93 Percentages of Subjects Interval 87.0 to 97.0	96 Percentages of Subjects Interval 85.0 to 99.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 15	100 Percentages of Subjects Interval 91.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0	98 Percentages of Subjects Interval 88.0 to 100.0	99 Percentages of Subjects Interval 96.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 22	100 Percentages of Subjects Interval 91.0 to 100.0	98 Percentages of Subjects Interval 88.0 to 100.0	98 Percentages of Subjects Interval 88.0 to 100.0	98 Percentages of Subjects Interval 95.0 to 100.0	98 Percentages of Subjects Interval 89.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 29	100 Percentages of Subjects Interval 91.0 to 100.0	98 Percentages of Subjects Interval 88.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0	99 Percentages of Subjects Interval 96.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 43	98 Percentages of Subjects Interval 87.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0	98 Percentages of Subjects Interval 88.0 to 100.0	100 Percentages of Subjects Interval 97.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 217 (N=0,0,35,111,34)	NA Percentages of Subjects No subjects were analyzed for this group.	NA Percentages of Subjects No subjects were analyzed for this group.	97 Percentages of Subjects Interval 85.0 to 100.0	91 Percentages of Subjects Interval 84.0 to 96.0	97 Percentages of Subjects Interval 85.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 387 (N=38,40,38,120,42)	76 Percentages of Subjects Interval 60.0 to 89.0	90 Percentages of Subjects Interval 76.0 to 97.0	92 Percentages of Subjects Interval 79.0 to 98.0	84 Percentages of Subjects Interval 76.0 to 90.0	83 Percentages of Subjects Interval 69.0 to 93.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 8	95 Percentages of Subjects Interval 83.0 to 99.0	80 Percentages of Subjects Interval 65.0 to 90.0	93 Percentages of Subjects Interval 82.0 to 99.0	86 Percentages of Subjects Interval 78.0 to 91.0	94 Percentages of Subjects Interval 82.0 to 99.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 15	98 Percentages of Subjects Interval 87.0 to 100.0	100 Percentages of Subjects Interval 92.0 to 100.0	98 Percentages of Subjects Interval 88.0 to 100.0	94 Percentages of Subjects Interval 88.0 to 97.0	98 Percentages of Subjects Interval 89.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 22	95 Percentages of Subjects Interval 83.0 to 99.0	91 Percentages of Subjects Interval 79.0 to 98.0	96 Percentages of Subjects Interval 85.0 to 99.0	94 Percentages of Subjects Interval 88.0 to 97.0	96 Percentages of Subjects Interval 85.0 to 99.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 29	95 Percentages of Subjects Interval 83.0 to 99.0	93 Percentages of Subjects Interval 82.0 to 99.0	98 Percentages of Subjects Interval 88.0 to 100.0	95 Percentages of Subjects Interval 90.0 to 98.0	98 Percentages of Subjects Interval 89.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 43	85 Percentages of Subjects Interval 71.0 to 94.0	93 Percentages of Subjects Interval 82.0 to 99.0	96 Percentages of Subjects Interval 85.0 to 99.0	95 Percentages of Subjects Interval 90.0 to 98.0	98 Percentages of Subjects Interval 89.0 to 100.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 217 (N=0,0,35,111,34)	NA Percentages of Subjects No subjects were analyzed for this group.	NA Percentages of Subjects No subjects were analyzed for this group.	94 Percentages of Subjects Interval 81.0 to 99.0	81 Percentages of Subjects Interval 73.0 to 88.0	88 Percentages of Subjects Interval 73.0 to 97.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years Seroconversion on day 387 (N=38,40,38,120,42)	66 Percentages of Subjects Interval 49.0 to 80.0	80 Percentages of Subjects Interval 64.0 to 91.0	87 Percentages of Subjects Interval 72.0 to 96.0	75 Percentages of Subjects Interval 66.0 to 82.0	69 Percentages of Subjects Interval 53.0 to 82.0
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years HI Titer ≥40 on day 1	20 Percentages of Subjects Interval 9.0 to 35.0	22 Percentages of Subjects Interval 11.0 to 37.0	13 Percentages of Subjects Interval 5.0 to 27.0	18 Percentages of Subjects Interval 12.0 to 26.0	21 Percentages of Subjects Interval 11.0 to 36.0

SECONDARY outcome

Timeframe: 7 days after each vaccination

Population: The analysis is done on the safety set.

Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to \<9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination

Outcome measures

Outcome measures
Measure	15_1_22 n=55 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=84 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=54 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Local Reactions postvac. 1	25 Number of subjects	31 Number of subjects	20 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Erythema postvac. 1	1 Number of subjects	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Induration postvac. 1	0 Number of subjects	3 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Swelling postvac. 1	3 Number of subjects	4 Number of subjects	3 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Tenderness postvac. 1	21 Number of subjects	23 Number of subjects	17 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Pain postvac. 1	21 Number of subjects	25 Number of subjects	17 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Systemic Reaction postvac. 1	24 Number of subjects	28 Number of subjects	17 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Headache postvac. 1	7 Number of subjects	12 Number of subjects	9 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Fatigue postvac. 1	6 Number of subjects	8 Number of subjects	5 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Myalgia postvac. 1	4 Number of subjects	8 Number of subjects	6 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Arthralgia postvac. 1	0 Number of subjects	2 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Chills postvac. 1	3 Number of subjects	1 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Nausea postvac. 1	5 Number of subjects	7 Number of subjects	4 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Vomiting postvac. 1	0 Number of subjects	1 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Diarrhea postvac. 1	0 Number of subjects	0 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Other Reactions postvac. 1	10 Number of subjects	10 Number of subjects	6 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Analges/Antipyr Used postvac. 1 (N=55, 83, 54)	9 Number of subjects	8 Number of subjects	6 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Stayed Home postvac.1(N=55,83,54)	1 Number of subjects	2 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Body Temp > 40 C postvac.1	0 Number of subjects	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Local Reactions postvac. 2 (N=55, 83, 54)	20 Number of subjects	29 Number of subjects	21 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Erythema postvac. 2 (N=55, 83, 54)	3 Number of subjects	1 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Induration postvac. 2 (N=55, 83, 54)	8 Number of subjects	1 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Swelling postvac. 2 (N=55, 83, 54)	8 Number of subjects	0 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Tenderness postvac. 2 (N=55, 83, 54)	15 Number of subjects	27 Number of subjects	16 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Pain postvac. 2 (N=55, 83, 54)	18 Number of subjects	23 Number of subjects	19 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Systemic Reaction postvac. 2 (N=55, 83, 54)	13 Number of subjects	22 Number of subjects	18 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Headache postvac. 2 (N=55, 83, 54)	5 Number of subjects	12 Number of subjects	3 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Fatigue postvac. 2 (N=55, 83, 54)	1 Number of subjects	5 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Myalgia postvac. 2 (N=55, 83, 54)	3 Number of subjects	2 Number of subjects	5 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Arthralgia postvac. 2 (N=55, 83, 54)	0 Number of subjects	2 Number of subjects	5 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Chills postvac. 2 (N=55, 83, 54)	2 Number of subjects	2 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Nausea postvac. 2 (N=55, 83, 54)	5 Number of subjects	5 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Vomiting postvac. 2 (N=55, 83, 54)	0 Number of subjects	1 Number of subjects	3 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Diarrhea postvac. 2 (N=55, 83, 54)	0 Number of subjects	1 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Other Reactions postvac. 2 (N=55, 82, 54)	5 Number of subjects	7 Number of subjects	7 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Analges/Antipyr Used postvac. 2 (N=55, 83, 54)	4 Number of subjects	6 Number of subjects	7 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Stayed Home postvac. 2 (N=55, 82, 54)	1 Number of subjects	2 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age Body Temp > 40 C postvac. 2 (N=55, 83, 54)	0 Number of subjects	0 Number of subjects	0 Number of subjects	—	—

SECONDARY outcome

Timeframe: 7 days after each vaccination

Population: The analysis is done on the safety set.

Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.

Outcome measures

Outcome measures
Measure	15_1_22 n=53 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=84 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=57 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 A/H1N1 7.5 mcg with MF59; two doses on day 1
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Systemic Reaction postvac. 2 (N=52, 84, 55)	18 Number of subjects	29 Number of subjects	14 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Local Reactions postvac. 1	37 Number of subjects	36 Number of subjects	29 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Erythema postvac. 1	1 Number of subjects	1 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Induration postvac. 1	1 Number of subjects	6 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Swelling postvac. 1	1 Number of subjects	4 Number of subjects	3 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Tenderness postvac. 1	26 Number of subjects	23 Number of subjects	21 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Pain postvac. 1	32 Number of subjects	30 Number of subjects	25 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Systemic Reaction postvac. 1	24 Number of subjects	36 Number of subjects	16 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Headache postvac. 1	17 Number of subjects	20 Number of subjects	8 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Fatigue postvac. 1	9 Number of subjects	13 Number of subjects	11 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Myalgia postvac. 1	11 Number of subjects	15 Number of subjects	11 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Arthralgia postvac. 1	2 Number of subjects	2 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Chills postvac. 1	1 Number of subjects	2 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Nausea postvac. 1	3 Number of subjects	7 Number of subjects	5 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Vomiting postvac. 1	0 Number of subjects	1 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Diarrhea postvac. 1	2 Number of subjects	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Other Reactions postvac. 1	11 Number of subjects	10 Number of subjects	8 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Analgesic/Antipyretic Used postvac. 1	10 Number of subjects	10 Number of subjects	7 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Stayed Home postvac. 1	2 Number of subjects	1 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Body Temp > 40 C postvac. 1	0 Number of subjects	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Local Reactions postvac. 2 (N=52, 84, 55)	31 Number of subjects	36 Number of subjects	27 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Erythema postvac. 2 (N=52, 84, 55)	0 Number of subjects	3 Number of subjects	1 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Induration postvac. 2 (N=52, 84, 55)	2 Number of subjects	3 Number of subjects	4 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Swelling postvac. 2 (N=52, 84, 55)	2 Number of subjects	5 Number of subjects	3 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Tenderness postvac. 2 (N=52, 84, 55)	20 Number of subjects	25 Number of subjects	25 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Pain postvac. 2 (N=52, 84, 55)	27 Number of subjects	30 Number of subjects	26 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Headache postvac. 2 (N=52, 84, 55)	12 Number of subjects	16 Number of subjects	8 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Fatigue postvac. 2 (N=52, 84, 55)	3 Number of subjects	6 Number of subjects	9 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Myalgia postvac. 2 (N=52, 84, 55)	8 Number of subjects	9 Number of subjects	7 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Arthralgia postvac. 2 (N=52, 84, 55)	0 Number of subjects	4 Number of subjects	4 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Chills postvac. 2 (N=52, 84, 55)	2 Number of subjects	2 Number of subjects	3 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Nausea postvac. 2 (N=52, 84, 55)	3 Number of subjects	7 Number of subjects	2 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Vomiting postvac. 2 (N=52, 84, 55)	1 Number of subjects	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Diarrhea postvac. 2 (N=52, 84, 55)	2 Number of subjects	3 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Other Reactions postvac. 2 (N=52, 84, 55)	1 Number of subjects	10 Number of subjects	4 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Analges/Antipyr Used postvac. 2 (N=52, 84, 55)	1 Number of subjects	9 Number of subjects	4 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Stayed Home postvac. 2 (N=52, 84, 55)	0 Number of subjects	1 Number of subjects	0 Number of subjects	—	—
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age Body Temp > 40 C postvac. 2 (N=52, 84, 55)	0 Number of subjects	0 Number of subjects	0 Number of subjects	—	—

SECONDARY outcome

Timeframe: 7 days after each vaccination

Population: The analysis is done on the safety set.

Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.

Outcome measures

Outcome measures
Measure	15_1_22 n=54 Participants A/H1N1 15 mcg no MF59; one dose on days 1 and 22	7.5adj_1_8 n=56 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_22 n=56 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	15_1_22 n=159 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1	2x15_1_22 n=54 Participants A/H1N1 7.5 mcg with MF59; two doses on day 1
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Other Reactions postvac. 1	14 Number of subjects	7 Number of subjects	12 Number of subjects	13 Number of subjects	5 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Local Reactions postvac. 1	39 Number of subjects	26 Number of subjects	38 Number of subjects	56 Number of subjects	19 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Erythema postvac. 1	3 Number of subjects	0 Number of subjects	2 Number of subjects	2 Number of subjects	1 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Induration postvac. 1	5 Number of subjects	4 Number of subjects	5 Number of subjects	6 Number of subjects	3 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Swelling postvac. 1	3 Number of subjects	3 Number of subjects	5 Number of subjects	4 Number of subjects	2 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Tenderness postvac. 1	33 Number of subjects	21 Number of subjects	26 Number of subjects	35 Number of subjects	14 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Pain postvac. 1	36 Number of subjects	23 Number of subjects	32 Number of subjects	41 Number of subjects	16 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Systemic Reaction postvac. 1	34 Number of subjects	31 Number of subjects	31 Number of subjects	71 Number of subjects	22 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Headache postvac. 1	26 Number of subjects	18 Number of subjects	22 Number of subjects	42 Number of subjects	12 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Fatigue postvac. 1	17 Number of subjects	16 Number of subjects	16 Number of subjects	32 Number of subjects	15 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Myalgia postvac. 1	21 Number of subjects	13 Number of subjects	16 Number of subjects	28 Number of subjects	12 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Arthralgia postvac. 1	4 Number of subjects	1 Number of subjects	6 Number of subjects	10 Number of subjects	2 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Chills postvac. 1	4 Number of subjects	3 Number of subjects	6 Number of subjects	6 Number of subjects	4 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Nausea postvac. 1	7 Number of subjects	9 Number of subjects	8 Number of subjects	16 Number of subjects	13 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Vomiting postvac. 1	0 Number of subjects	0 Number of subjects	0 Number of subjects	1 Number of subjects	1 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Diarrhea postvac. 1	2 Number of subjects	1 Number of subjects	0 Number of subjects	8 Number of subjects	3 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Analgesic/Antipyretic Used postvac. 1	14 Number of subjects	6 Number of subjects	12 Number of subjects	13 Number of subjects	4 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Stayed Home postvac. 1 (N=53,55,56,157,54)	2 Number of subjects	1 Number of subjects	2 Number of subjects	0 Number of subjects	1 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Body Temp > 40 C postvac. 1	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects	0 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Local Reactions postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	21 Number of subjects	28 Number of subjects	56 Number of subjects	17 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Erythema postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	1 Number of subjects	2 Number of subjects	5 Number of subjects	1 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Induration postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	3 Number of subjects	4 Number of subjects	4 Number of subjects	3 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Swelling postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	2 Number of subjects	5 Number of subjects	7 Number of subjects	5 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Tenderness postvac. 2 (N=0,55,56,157853)	0 Number of subjects	16 Number of subjects	24 Number of subjects	48 Number of subjects	16 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Pain postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	19 Number of subjects	24 Number of subjects	45 Number of subjects	15 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Systemic Reaction postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	26 Number of subjects	28 Number of subjects	53 Number of subjects	14 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Headache postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	18 Number of subjects	18 Number of subjects	25 Number of subjects	11 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Fatigue postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	14 Number of subjects	13 Number of subjects	24 Number of subjects	10 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Myalgia postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	9 Number of subjects	14 Number of subjects	26 Number of subjects	7 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Arthralgia postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	5 Number of subjects	7 Number of subjects	16 Number of subjects	4 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Chills postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	8 Number of subjects	5 Number of subjects	5 Number of subjects	8 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Nausea postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	8 Number of subjects	5 Number of subjects	7 Number of subjects	3 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Vomiting postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	1 Number of subjects	0 Number of subjects	2 Number of subjects	1 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Diarrhea postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	1 Number of subjects	0 Number of subjects	4 Number of subjects	1 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Other Reactions postvac. 2 (N=0,55,56,158, 53)	0 Number of subjects	8 Number of subjects	7 Number of subjects	11 Number of subjects	7 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53)	0 Number of subjects	7 Number of subjects	7 Number of subjects	11 Number of subjects	6 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Stayed Home postvaccination 2 (N=0,53,0,156,53)	0 Number of subjects	2 Number of subjects	0 Number of subjects	1 Number of subjects	2 Number of subjects
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age Body Temp > 40 C postvac. 2 (N=0,55,56,158,53)	0 Number of subjects	0 Number of subjects	0 Number of subjects	1 Number of subjects	0 Number of subjects

Adverse Events

2x7.5adj (18 to 64 Yrs)

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

7.5adj_1_8 (18 to 64 Yrs)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

7.5adj_1_22 (18-64 Yrs)

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

15_1_22 (18 to 64 Yrs)

Serious events: 4 serious events

Other events: 119 other events

Deaths: 0 deaths

2x15_1_22 (18 to 64 Yrs)

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

7.5adj_1_22 (9 to 17 Yrs)

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

15_1_22 (9 to 17 Yrs)

Serious events: 1 serious events

Other events: 67 other events

Deaths: 0 deaths

2x15_1_22 (9 to 17 Yrs)

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

7.5adj_1_22 (3 to <9 Yrs)

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

15_1_22 (3 to <9 Yrs)

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

2x15_1_22 (3 to <9 Yrs)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2x7.5adj (18 to 64 Yrs) n=54 participants at risk A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_8 (18 to 64 Yrs) n=56 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8	7.5adj_1_22 (18-64 Yrs) n=56 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 (18 to 64 Yrs) n=159 participants at risk A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 (18 to 64 Yrs) n=54 participants at risk A/H1N1 15 mcg no MF59; two doses on days 1 and 22	7.5adj_1_22 (9 to 17 Yrs) n=53 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 (9 to 17 Yrs) n=84 participants at risk A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 (9 to 17 Yrs) n=57 participants at risk A/H1N1 15 mcg no MF59; two doses on days 1 and 22	7.5adj_1_22 (3 to <9 Yrs) n=55 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 (3 to <9 Yrs) n=84 participants at risk A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 (3 to <9 Yrs) n=54 participants at risk A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Infections and infestations appendicitis	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.2% 1/84 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Surgical and medical procedures rhinoplasty	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Endocrine disorders Precocious Puberty	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/55 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Social circumstances sexual abuse	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/55 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Gastrointestinal disorders abdominal pain	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/53 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Infections and infestations urinary tract infection	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Musculoskeletal and connective tissue disorders intervertebral disc protrusion	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) brain neoplasm	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) breast cancer	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Pregnancy, puerperium and perinatal conditions abortion threatened	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Pregnancy, puerperium and perinatal conditions high risk pregnancy	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Renal and urinary disorders nephrolithiasis	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Reproductive system and breast disorders uterine haemorrhage	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Surgical and medical procedures hysterectomy	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Surgical and medical procedures inguinal hernia repair	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.

Other adverse events

Other adverse events
Measure	2x7.5adj (18 to 64 Yrs) n=54 participants at risk A/H1N1 7.5 mcg with MF59; two doses on day 1	7.5adj_1_8 (18 to 64 Yrs) n=56 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8	7.5adj_1_22 (18-64 Yrs) n=56 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 (18 to 64 Yrs) n=159 participants at risk A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 (18 to 64 Yrs) n=54 participants at risk A/H1N1 15 mcg no MF59; two doses on days 1 and 22	7.5adj_1_22 (9 to 17 Yrs) n=53 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 (9 to 17 Yrs) n=84 participants at risk A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 (9 to 17 Yrs) n=57 participants at risk A/H1N1 15 mcg no MF59; two doses on days 1 and 22	7.5adj_1_22 (3 to <9 Yrs) n=55 participants at risk A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22	15_1_22 (3 to <9 Yrs) n=84 participants at risk A/H1N1 15 mcg no MF59; one dose on days 1 and 22	2x15_1_22 (3 to <9 Yrs) n=54 participants at risk A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Infections and infestations nasopharyngitis	18.5% 10/54 • Number of events 11 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	10.7% 6/56 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	14.3% 8/56 • Number of events 8 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	15.1% 24/159 • Number of events 26 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.1% 6/54 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	13.2% 7/53 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	14.3% 12/84 • Number of events 15 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	19.3% 11/57 • Number of events 12 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.3% 4/55 • Number of events 6 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	20.2% 17/84 • Number of events 20 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	20.4% 11/54 • Number of events 15 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Infections and infestations upper respiratory tract infection	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 2/56 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	8.9% 5/56 • Number of events 6 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.8% 6/159 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/53 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 3/84 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.3% 3/57 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.3% 4/55 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	8.3% 7/84 • Number of events 9 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.1% 6/54 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Respiratory, thoracic and mediastinal disorders cough	3.7% 2/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 2/56 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.0% 8/159 • Number of events 9 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.6% 3/54 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	4.8% 4/84 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/57 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.1% 6/84 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.4% 4/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Nervous system disorders headache	50.0% 27/54 • Number of events 31 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	37.5% 21/56 • Number of events 49 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	48.2% 27/56 • Number of events 57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	35.2% 56/159 • Number of events 91 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	31.5% 17/54 • Number of events 30 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	39.6% 21/53 • Number of events 39 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	34.5% 29/84 • Number of events 48 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	19.3% 11/57 • Number of events 22 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	20.0% 11/55 • Number of events 12 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	25.0% 21/84 • Number of events 31 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	20.4% 11/54 • Number of events 15 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Musculoskeletal and connective tissue disorders myalgia	38.9% 21/54 • Number of events 28 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	30.4% 17/56 • Number of events 25 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	37.5% 21/56 • Number of events 34 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	26.4% 42/159 • Number of events 73 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	31.5% 17/54 • Number of events 22 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	34.0% 18/53 • Number of events 22 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	23.8% 20/84 • Number of events 26 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	24.6% 14/57 • Number of events 22 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	9.1% 5/55 • Number of events 8 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.9% 10/84 • Number of events 12 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	16.7% 9/54 • Number of events 13 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
General disorders injection site erythema	5.6% 3/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.4% 3/56 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.8% 6/159 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.7% 2/54 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/53 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	4.8% 4/84 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/57 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.5% 3/55 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.2% 1/84 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
General disorders injection site pain	72.2% 39/54 • Number of events 130 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	55.4% 31/56 • Number of events 79 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	75.0% 42/56 • Number of events 113 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	49.7% 79/159 • Number of events 173 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	42.6% 23/54 • Number of events 108 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	79.2% 42/53 • Number of events 116 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	61.9% 52/84 • Number of events 117 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	64.9% 37/57 • Number of events 160 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	58.2% 32/55 • Number of events 75 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	51.2% 43/84 • Number of events 102 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	53.7% 29/54 • Number of events 116 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
General disorders injection site swelling	1.9% 1/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 2/56 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 2/56 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.1% 5/159 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.7% 2/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/53 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	2.4% 2/84 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/57 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.5% 3/55 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	2.4% 2/84 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.7% 2/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Gastrointestinal disorders nausea	13.0% 7/54 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	23.2% 13/56 • Number of events 23 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	19.6% 11/56 • Number of events 17 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	13.2% 21/159 • Number of events 28 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	9.3% 5/54 • Number of events 8 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.3% 6/53 • Number of events 6 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	14.3% 12/84 • Number of events 16 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	10.5% 6/57 • Number of events 11 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	14.5% 8/55 • Number of events 10 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.9% 10/84 • Number of events 14 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	9.3% 5/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
General disorders pyrexia	3.7% 2/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.1% 4/56 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	10.7% 6/56 • Number of events 8 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.5% 12/159 • Number of events 13 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.7% 2/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.7% 3/53 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 3/84 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	10.5% 6/57 • Number of events 8 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	14.5% 8/55 • Number of events 8 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.9% 10/84 • Number of events 13 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	18.5% 10/54 • Number of events 12 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
General disorders fatigue	31.5% 17/54 • Number of events 20 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	35.7% 20/56 • Number of events 34 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	37.5% 21/56 • Number of events 36 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	28.3% 45/159 • Number of events 73 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	33.3% 18/54 • Number of events 30 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	20.8% 11/53 • Number of events 13 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	17.9% 15/84 • Number of events 23 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	24.6% 14/57 • Number of events 26 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	10.9% 6/55 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	13.1% 11/84 • Number of events 16 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.1% 6/54 • Number of events 9 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Musculoskeletal and connective tissue disorders arthralgia	7.4% 4/54 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	10.7% 6/56 • Number of events 6 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	17.9% 10/56 • Number of events 14 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	15.1% 24/159 • Number of events 32 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.4% 4/54 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.8% 2/53 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	6.0% 5/84 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	8.8% 5/57 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	4.8% 4/84 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	13.0% 7/54 • Number of events 7 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Gastrointestinal disorders vomiting	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 3/159 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/53 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 3/84 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/57 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	2.4% 2/84 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	9.3% 5/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Nervous system disorders dizziness	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.4% 3/56 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/57 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
General disorders chills	7.4% 4/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	16.1% 9/56 • Number of events 11 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	14.3% 8/56 • Number of events 12 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	6.3% 10/159 • Number of events 12 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	20.4% 11/54 • Number of events 14 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.7% 3/53 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	4.8% 4/84 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.0% 4/57 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.3% 4/55 • Number of events 6 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	2.4% 2/84 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.7% 2/54 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Gastrointestinal disorders diarrhea	3.7% 2/54 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 2/56 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	8.2% 13/159 • Number of events 13 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.6% 3/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	7.5% 4/53 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	6.0% 5/84 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/55 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 3/84 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	9.3% 5/54 • Number of events 5 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Infections and infestations tonsillitis	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.5% 3/55 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 3/84 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	11.1% 6/54 • Number of events 6 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Infections and infestations varicella	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/56 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/159 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/55 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.6% 3/54 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Musculoskeletal and connective tissue disorders pain in extremity	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.4% 3/56 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.6% 2/56 • Number of events 2 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.63% 1/159 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.9% 1/54 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.2% 1/84 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
Musculoskeletal and connective tissue disorders backpain	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.8% 1/56 • Number of events 1 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	5.4% 3/56 • Number of events 4 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	1.3% 2/159 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	3.7% 2/54 • Number of events 3 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/53 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/57 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/55 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/84 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.	0.00% 0/54 • All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387). Data provided in Other Adverse Events (\>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place