Trial Outcomes & Findings for Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old (NCT NCT02035696)

NCT ID: NCT02035696

Last Updated: 2018-07-10

Results Overview

Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to \<48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

671 participants

Primary outcome timeframe

Day 50/Day 1

Results posted on

2018-07-10

Participant Flow

6 centers in the United States, 1 center in Finland, 2 centers in Thailand, 2 centers in Philippines

All enrolled Subjects were included in the trial

Participant milestones

Participant milestones
Measure	TIVc-High Dose Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Overall Study STARTED	174	166	167	164
Overall Study COMPLETED	171	163	164	161
Overall Study NOT COMPLETED	3	3	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	TIVc-High Dose Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Overall Study Lost to Follow-up	0	3	1	2
Overall Study Withdrawal by Subject	3	0	2	1

Baseline Characteristics

Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIVc-High Dose n=174 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=166 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=167 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=164 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine	Total n=671 Participants Total of all reporting groups
Age, Continuous	25.3 Months STANDARD_DEVIATION 11.5 • n=5 Participants	25.0 Months STANDARD_DEVIATION 11.5 • n=7 Participants	25.6 Months STANDARD_DEVIATION 11.5 • n=5 Participants	25.3 Months STANDARD_DEVIATION 11.9 • n=4 Participants	25.3 Months STANDARD_DEVIATION 11.6 • n=21 Participants
Sex: Female, Male FEMALE	84 Participants n=5 Participants	82 Participants n=7 Participants	77 Participants n=5 Participants	87 Participants n=4 Participants	330 Participants n=21 Participants
Sex: Female, Male MALE	90 Participants n=5 Participants	84 Participants n=7 Participants	90 Participants n=5 Participants	77 Participants n=4 Participants	341 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 50/Day 1

Population: Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=156 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=147 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=141 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=145 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1	7.82 Ratios Interval 4.3 to 14.21	5.5 Ratios Interval 3.01 to 10.04	5.93 Ratios Interval 3.21 to 10.96	3.69 Ratios Interval 2.02 to 6.74
Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2	10.53 Ratios Interval 6.34 to 17.49	10.84 Ratios Interval 6.5 to 18.07	6.47 Ratios Interval 3.84 to 10.9	11.95 Ratios Interval 7.17 to 19.91
Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine B	5.18 Ratios Interval 3.73 to 7.96	4.27 Ratios Interval 2.77 to 6.58	3.87 Ratios Interval 2.49 to 6.02	6.65 Ratios Interval 4.32 to 10.25

PRIMARY outcome

Timeframe: Day 50 post vaccination

Population: Analysis was done on PP population

Immunogenicity was assessed in terms number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=156 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=147 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=141 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=145 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine B_Day 50	69 Percentages of subjects Interval 61.0 to 76.0	69 Percentages of subjects Interval 61.0 to 77.0	62 Percentages of subjects Interval 54.0 to 70.0	80 Percentages of subjects Interval 73.0 to 86.0
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1_Day 50	83 Percentages of subjects Interval 77.0 to 89.0	81 Percentages of subjects Interval 74.0 to 87.0	79 Percentages of subjects Interval 72.0 to 86.0	74 Percentages of subjects Interval 66.0 to 81.0
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2_Day 50	94 Percentages of subjects Interval 89.0 to 97.0	90 Percentages of subjects Interval 84.0 to 94.0	87 Percentages of subjects Interval 80.0 to 92.0	92 Percentages of subjects Interval 87.0 to 96.0

PRIMARY outcome

Timeframe: Day 1 to Day 3

Population: Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).

Differences in percentages of subjects (6 to \<48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=305 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=294 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=291 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine Severe solicited local AEs	0.000 percentage of participants	0.000 percentage of participants	0.000 percentage of participants	—
Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine Severe solicited systemic AEs	0.040 percentage of participants	0.000 percentage of participants	0.000 percentage of participants	—

SECONDARY outcome

Timeframe: Day 50 post vaccination

Population: Analysis was done on Full analysis set

Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers \>40%

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=170 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=164 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=161 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=159 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1	84 Percentages of subjects Interval 77.0 to 89.0	80 Percentages of subjects Interval 74.0 to 86.0	82 Percentages of subjects Interval 75.0 to 88.0	73 Percentages of subjects Interval 65.0 to 80.0
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2	94 Percentages of subjects Interval 89.0 to 97.0	91 Percentages of subjects Interval 85.0 to 95.0	88 Percentages of subjects Interval 81.0 to 92.0	93 Percentages of subjects Interval 88.0 to 96.0
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine B	68 Percentages of subjects Interval 61.0 to 75.0	70 Percentages of subjects Interval 62.0 to 76.0	63 Percentages of subjects Interval 55.0 to 70.0	79 Percentages of subjects Interval 72.0 to 85.0

SECONDARY outcome

Timeframe: Day 1, Day 50 post vaccination

Population: Analysis was done on FAS

Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be \>70%

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=170 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=164 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=161 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=159 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 1	45 Percentages of subjects Interval 37.0 to 53.0	40 Percentages of subjects Interval 33.0 to 48.0	48 Percentages of subjects Interval 41.0 to 56.0	52 Percentages of subjects Interval 44.0 to 60.0
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 1	26 Percentages of subjects Interval 20.0 to 34.0	32 Percentages of subjects Interval 25.0 to 39.0	29 Percentages of subjects Interval 22.0 to 37.0	26 Percentages of subjects Interval 20.0 to 34.0
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 50	86 Percentages of subjects Interval 80.0 to 91.0	85 Percentages of subjects Interval 78.0 to 90.0	86 Percentages of subjects Interval 79.0 to 91.0	77 Percentages of subjects Interval 69.0 to 83.0
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 50	98 Percentages of subjects Interval 95.0 to 100.0	98 Percentages of subjects Interval 94.0 to 99.0	97 Percentages of subjects Interval 93.0 to 99.0	99 Percentages of subjects Interval 97.0 to 100.0
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 1	2 Percentages of subjects Interval 0.0 to 5.0	0 Percentages of subjects Interval 0.0 to 2.0	1 Percentages of subjects Interval 0.016 to 3.0	3 Percentages of subjects Interval 1.0 to 7.0
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 50	69 Percentages of subjects Interval 61.0 to 76.0	70 Percentages of subjects Interval 62.0 to 76.0	63 Percentages of subjects Interval 55.0 to 70.0	80 Percentages of subjects Interval 73.0 to 86.0

SECONDARY outcome

Timeframe: Day 50 post vaccination over day 1

Population: Analysis was done on FAS

Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) \>2.5

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=170 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=164 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=161 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=159 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1	12 Ratios Interval 7.05 to 19.0	8.58 Ratios Interval 5.08 to 14.0	8.94 Ratios Interval 5.28 to 15.0	5.14 Ratios Interval 3.04 to 8.68
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2	12 Ratios Interval 7.83 to 19.0	13 Ratios Interval 8.05 to 20.0	7.68 Ratios Interval 4.91 to 12.0	14 Ratios Interval 8.83 to 22.0
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine B	6.14 Ratios Interval 4.27 to 8.84	5.29 Ratios Interval 3.64 to 7.7	4.72 Ratios Interval 3.24 to 6.88	7.57 Ratios Interval 5.21 to 11.0

SECONDARY outcome

Timeframe: Day 50 post vaccination over day 1

Population: Analysis was done on PPS

Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=156 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=148 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=141 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=147 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine B	12.78 Ratios Interval 8.09 to 20.2	10.43 Ratios Interval 6.58 to 16.52	9.99 Ratios Interval 6.25 to 15.99	17.55 Ratios Interval 11.08 to 27.78
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1	7.84 Ratios Interval 4.29 to 14.33	5.81 Ratios Interval 3.17 to 10.65	5.98 Ratios Interval 3.22 to 11.09	17.82 Ratios Interval 9.73 to 32.62
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2	8.4 Ratios Interval 5.0 to 14.12	8.97 Ratios Interval 5.32 to 15.12	5.58 Ratios Interval 3.28 to 9.51	8.9 Ratios Interval 5.28 to 14.98

SECONDARY outcome

Timeframe: Day 1 and Day 50 post vaccination

Population: Analysis was done on PPS

Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=156 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=147 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=141 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=145 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 1: HI titers ≥1:110	26 Percentages of subjects Interval 19.0 to 33.0	31 Percentages of subjects Interval 24.0 to 39.0	26 Percentages of subjects Interval 19.0 to 34.0	26 Percentages of subjects Interval 19.0 to 33.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 50: HI titers ≥1:110	78 Percentages of subjects Interval 70.0 to 84.0	80 Percentages of subjects Interval 72.0 to 86.0	71 Percentages of subjects Interval 63.0 to 78.0	59 Percentages of subjects Interval 51.0 to 67.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 1: HI titers ≥1:110	40 Percentages of subjects Interval 33.0 to 49.0	37 Percentages of subjects Interval 29.0 to 45.0	43 Percentages of subjects Interval 34.0 to 51.0	47 Percentages of subjects Interval 39.0 to 55.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 50: HI titers ≥1:110	88 Percentages of subjects Interval 82.0 to 93.0	86 Percentages of subjects Interval 80.0 to 91.0	82 Percentages of subjects Interval 74.0 to 88.0	97 Percentages of subjects Interval 93.0 to 99.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 1: HI titers ≥1:110	1 Percentages of subjects Interval 0.016 to 4.0	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 3.0	0 Percentages of subjects Interval 0.0 to 3.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 50: HI titers ≥1:110	40 Percentages of subjects Interval 33.0 to 49.0	30 Percentages of subjects Interval 23.0 to 38.0	24 Percentages of subjects Interval 17.0 to 32.0	39 Percentages of subjects Interval 31.0 to 47.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 1: HI titers ≥1:151	25 Percentages of subjects Interval 18.0 to 33.0	30 Percentages of subjects Interval 23.0 to 38.0	26 Percentages of subjects Interval 19.0 to 34.0	25 Percentages of subjects Interval 18.0 to 33.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 50: HI titers ≥1:151	76 Percentages of subjects Interval 69.0 to 83.0	76 Percentages of subjects Interval 68.0 to 83.0	70 Percentages of subjects Interval 62.0 to 78.0	58 Percentages of subjects Interval 49.0 to 66.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 1: HI titers ≥1:151	40 Percentages of subjects Interval 33.0 to 49.0	37 Percentages of subjects Interval 29.0 to 45.0	43 Percentages of subjects Interval 34.0 to 51.0	47 Percentages of subjects Interval 39.0 to 55.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 50: HI titers ≥1:150	88 Percentages of subjects Interval 82.0 to 93.0	86 Percentages of subjects Interval 80.0 to 91.0	81 Percentages of subjects Interval 73.0 to 87.0	97 Percentages of subjects Interval 93.0 to 99.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 1: HI titers ≥1:151	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 3.0	0 Percentages of subjects Interval 0.0 to 3.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 50: HI titers ≥1:151	40 Percentages of subjects Interval 32.0 to 48.0	30 Percentages of subjects Interval 23.0 to 38.0	23 Percentages of subjects Interval 17.0 to 31.0	39 Percentages of subjects Interval 31.0 to 47.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 1: HI titers ≥1:330	12 Percentages of subjects Interval 7.0 to 18.0	14 Percentages of subjects Interval 9.0 to 21.0	11 Percentages of subjects Interval 7.0 to 18.0	11 Percentages of subjects Interval 6.0 to 17.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 50: HI titers ≥1:330	51 Percentages of subjects Interval 43.0 to 59.0	50 Percentages of subjects Interval 42.0 to 59.0	43 Percentages of subjects Interval 35.0 to 52.0	34 Percentages of subjects Interval 26.0 to 42.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 1: HI titers ≥1:330	16 Percentages of subjects Interval 11.0 to 23.0	12 Percentages of subjects Interval 7.0 to 18.0	13 Percentages of subjects Interval 8.0 to 19.0	21 Percentages of subjects Interval 15.0 to 29.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 50: HI titers ≥1:330	62 Percentages of subjects Interval 53.0 to 69.0	56 Percentages of subjects Interval 48.0 to 65.0	52 Percentages of subjects Interval 43.0 to 60.0	68 Percentages of subjects Interval 59.0 to 75.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 1: HI titers ≥1:330	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 3.0	0 Percentages of subjects Interval 0.0 to 3.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 50: HI titers ≥1:330	4 Percentages of subjects Interval 2.0 to 9.0	4 Percentages of subjects Interval 2.0 to 9.0	3 Percentages of subjects Interval 1.0 to 7.0	8 Percentages of subjects Interval 4.0 to 13.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 1: HI titers ≥1:629	9 Percentages of subjects Interval 5.0 to 15.0	12 Percentages of subjects Interval 7.0 to 18.0	11 Percentages of subjects Interval 6.0 to 17.0	8 Percentages of subjects Interval 4.0 to 14.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1: Day 50: HI titers ≥1:629	48 Percentages of subjects Interval 40.0 to 56.0	47 Percentages of subjects Interval 39.0 to 55.0	43 Percentages of subjects Interval 35.0 to 52.0	33 Percentages of subjects Interval 26.0 to 41.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 1: HI titers ≥1:629	16 Percentages of subjects Interval 11.0 to 23.0	12 Percentages of subjects Interval 7.0 to 18.0	12 Percentages of subjects Interval 7.0 to 19.0	21 Percentages of subjects Interval 15.0 to 29.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2: Day 50: HI titers ≥1:629	62 Percentages of subjects Interval 53.0 to 69.0	56 Percentages of subjects Interval 47.0 to 64.0	52 Percentages of subjects Interval 43.0 to 60.0	68 Percentages of subjects Interval 59.0 to 75.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 1: HI titers ≥1:629	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 2.0	0 Percentages of subjects Interval 0.0 to 3.0	0 Percentages of subjects Interval 0.0 to 3.0
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine B: Day 50: HI titers ≥1:629	4 Percentages of subjects Interval 2.0 to 9.0	3 Percentages of subjects Interval 1.0 to 8.0	3 Percentages of subjects Interval 1.0 to 7.0	7 Percentages of subjects Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: Day 1 and Day 50 post vaccination

Population: Analysis was done on PPS

Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=156 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=148 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=141 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=147 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1	94 Percentage of subjects Interval 89.0 to 97.0	93 Percentage of subjects Interval 88.0 to 97.0	91 Percentage of subjects Interval 86.0 to 96.0	97 Percentage of subjects Interval 93.0 to 99.0
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2	95 Percentage of subjects Interval 90.0 to 98.0	94 Percentage of subjects Interval 89.0 to 97.0	94 Percentage of subjects Interval 89.0 to 98.0	94 Percentage of subjects Interval 89.0 to 97.0
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine B	92 Percentage of subjects Interval 86.0 to 95.0	92 Percentage of subjects Interval 86.0 to 96.0	93 Percentage of subjects Interval 87.0 to 97.0	97 Percentage of subjects Interval 93.0 to 99.0

SECONDARY outcome

Timeframe: Day 1 and Day 50 post vaccination

Population: Analysis was done on PPS

Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=156 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=148 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=141 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=147 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H1N1	87 Percentages of subjects Interval 80.0 to 91.0	89 Percentages of subjects Interval 82.0 to 93.0	84 Percentages of subjects Interval 77.0 to 90.0	95 Percentages of subjects Interval 90.0 to 98.0
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine A/H3N2	85 Percentages of subjects Interval 79.0 to 90.0	85 Percentages of subjects Interval 78.0 to 90.0	82 Percentages of subjects Interval 74.0 to 88.0	80 Percentages of subjects Interval 73.0 to 86.0
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine B	83 Percentages of subjects Interval 76.0 to 88.0	87 Percentages of subjects Interval 81.0 to 92.0	83 Percentages of subjects Interval 76.0 to 89.0	96 Percentages of subjects Interval 91.0 to 98.0

SECONDARY outcome

Timeframe: Day 1 to Day 7

Population: Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h -day3, day4-day7 and 6h - day 7) as these subjects did not provide any post vaccination solicited safety data

Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=174 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=165 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=167 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=161 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Diarrhea	31 Subjects	31 Subjects	29 Subjects	34 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any local AEs	64 Subjects	56 Subjects	60 Subjects	54 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Injection site tenderness	50 Subjects	43 Subjects	42 Subjects	45 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Injection site erythema	19 Subjects	24 Subjects	24 Subjects	17 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Injection site induration	13 Subjects	14 Subjects	9 Subjects	8 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Injection site ecchymosis	9 Subjects	9 Subjects	7 Subjects	7 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any Systemic	78 Subjects	72 Subjects	69 Subjects	66 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Chills	7 Subjects	5 Subjects	7 Subjects	9 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Change in eating habits	29 Subjects	35 Subjects	28 Subjects	29 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Sleepiness	30 Subjects	28 Subjects	21 Subjects	24 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Irritability	30 Subjects	31 Subjects	29 Subjects	27 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Vomiting	21 Subjects	20 Subjects	22 Subjects	14 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Fever (≥ 38°C )	15 Subjects	20 Subjects	21 Subjects	21 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Prophylactic use of antipyretics/analgesics	9 Subjects	21 Subjects	25 Subjects	13 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Therapeutic use of antipyretics/analgesics	17 Subjects	21 Subjects	24 Subjects	22 Subjects

SECONDARY outcome

Timeframe: Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209

Population: Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data

Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 \[Post Vaccination\] to Day 29 \[Pre Clinic Visit\] and Day 29 \[Post Vaccination\] to Day 50 \[Pre Clinic Visit\] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)

Outcome measures

Outcome measures
Measure	TIVc-High Dose n=174 Participants Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=166 Participants Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=167 Participants Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=164 Participants Subjects (6 to \<48 months old) received two doses of TIVe vaccine
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any AEs(after any vaccination)	102 Subjects	107 Subjects	91 Subjects	94 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Possibly/probably related AEs (after any vaccin.)	38 Subjects	43 Subjects	43 Subjects	35 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any AEs(after vaccination 1)	79 Subjects	84 Subjects	69 Subjects	76 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any AEs(after vaccination 2)	56 Subjects	64 Subjects	50 Subjects	48 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Possibly/probably related AEs (after vaccination 1	30 Subjects	33 Subjects	31 Subjects	31 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Possibly/probably related AEs (after vaccination 2	11 Subjects	20 Subjects	18 Subjects	14 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any SAE	4 Subjects	8 Subjects	10 Subjects	6 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any possibly/probably related SAE	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Any AE leading to premature withdrawal from study	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine New onset of chronic disease	0 Subjects	1 Subjects	1 Subjects	1 Subjects
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine Death	0 Subjects	0 Subjects	0 Subjects	0 Subjects

Adverse Events

TIVc-High Dose

Serious events: 4 serious events

Other events: 142 other events

Deaths: 0 deaths

TIVc-Full Dose

Serious events: 8 serious events

Other events: 133 other events

Deaths: 0 deaths

TIVc- Half Dose

Serious events: 10 serious events

Other events: 141 other events

Deaths: 0 deaths

TIVe

Serious events: 6 serious events

Other events: 127 other events

Deaths: 0 deaths

Total

Serious events: 28 serious events

Other events: 543 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TIVc-High Dose n=174 participants at risk Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=166 participants at risk Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=167 participants at risk Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=164 participants at risk Subjects (6 to \<48 months old) received two doses of TIVe vaccine	Total n=671 participants at risk Total number of subjects
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations VIRAL INFECTION	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Skin and subcutaneous tissue disorders URTICARIA	0.57% 1/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders PYREXIA	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations BRONCHITIS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.2% 2/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.45% 3/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations PHARYNGITIS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations PNEUMONIA	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.2% 2/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.2% 2/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 4/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations VARICELLA	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Injury, poisoning and procedural complications ANIMAL BITE	0.57% 1/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.2% 2/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.75% 5/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Nervous system disorders FEBRILE CONVULSION	0.57% 1/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.2% 2/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.8% 3/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.0% 7/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	1.2% 2/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.45% 3/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Gastrointestinal disorders GASTRITIS	0.57% 1/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations ABSCESS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations AMOEBIASIS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.30% 2/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations GASTROENTERITIS	1.1% 2/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 4/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations HAND-FOOT-AND-MOUTH DISEASE	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations PERIORBITAL CELLULITIS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations PHARYNGOTONSILLITIS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations PSEUDOMONAL SEPSIS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.61% 1/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.60% 1/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.00% 0/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	0.15% 1/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event

Other adverse events

Other adverse events
Measure	TIVc-High Dose n=174 participants at risk Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine	TIVc-Full Dose n=166 participants at risk Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine	TIVc- Half Dose n=167 participants at risk Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine	TIVe n=164 participants at risk Subjects (6 to \<48 months old) received two doses of TIVe vaccine	Total n=671 participants at risk Total number of subjects
General disorders INJECTION SITE INDURATION	7.5% 13/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	9.6% 16/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	7.2% 12/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	6.1% 10/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	7.6% 51/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders INJECTION SITE PAIN	32.2% 56/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	28.9% 48/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	28.1% 47/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	28.7% 47/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	29.5% 198/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders PYREXIA	12.6% 22/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	16.9% 28/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	19.2% 32/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	13.4% 22/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	15.5% 104/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations NASOPHARYNGITIS	10.9% 19/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	10.2% 17/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	13.2% 22/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	15.2% 25/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	12.4% 83/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations RHINITIS	12.6% 22/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	18.1% 30/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	11.4% 19/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	15.9% 26/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	14.5% 97/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Psychiatric disorders EATING DISORDER	16.7% 29/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	21.1% 35/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	16.8% 28/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	17.7% 29/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	18.0% 121/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	27.6% 48/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	26.5% 44/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	31.7% 53/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	25.0% 41/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	27.7% 186/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Nervous system disorders SOMNOLENCE	17.2% 30/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	16.9% 28/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	12.6% 21/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	14.6% 24/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	15.4% 103/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Psychiatric disorders IRRITABILITY	19.5% 34/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	22.3% 37/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	20.4% 34/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	17.7% 29/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	20.0% 134/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders CHILLS	4.0% 7/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	3.0% 5/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	4.2% 7/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	5.5% 9/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	4.2% 28/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations BRONCHITIS	3.4% 6/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	6.6% 11/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	7.2% 12/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	7.3% 12/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	6.1% 41/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations Gastroenteritis	9.8% 17/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	10.2% 17/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	9.0% 15/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	9.1% 15/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	9.5% 64/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Infections and infestations Impetigo	3.4% 6/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	4.8% 8/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	6.0% 10/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	3.7% 6/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	4.5% 30/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders INJECTION SITE HAEMORRHAGE	5.2% 9/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	6.0% 10/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	4.8% 8/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	4.3% 7/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	5.1% 34/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Gastrointestinal disorders DIARRHOEA	18.4% 32/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	19.3% 32/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	18.0% 30/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	22.0% 36/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	19.4% 130/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
Gastrointestinal disorders VOMITING	12.1% 21/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	12.0% 20/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	13.2% 22/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	8.5% 14/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	11.5% 77/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders INFLUENZA LIKE ILLNESS	11.5% 20/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	22.9% 38/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	21.0% 35/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	22.6% 37/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	19.4% 130/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
General disorders INJECTION SITE ERYTHEMA	17.2% 30/174 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	21.7% 36/166 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	19.2% 32/167 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	17.7% 29/164 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event	18.9% 127/671 • Throughout the study period, up to day 209 post vaccination. Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event

Additional Information

Clinical Trial Disclosure Manager

Seqirus

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60