Trial Outcomes & Findings for Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age (NCT NCT01051661)

Last Updated: 2021-02-26

Results Overview

The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

6154 participants

Primary outcome timeframe

From 14 days after first vaccination until study conclusion on Day 385

Results posted on

2021-02-26

Participant Flow

Out of the 1654 subjects enrolled, study vaccine was not administered but subject number was allocated to 9 subjects. These 9 subjects were excluded from the study, therefore leading to 1645 subjects starting the study.

Participant milestones

Participant milestones
Measure	Arepanrix 2D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 2D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Overall Study STARTED	610	1438	612	1436	613	1436
Overall Study COMPLETED	576	1375	573	1380	578	1369
Overall Study NOT COMPLETED	34	63	39	56	35	67

Reasons for withdrawal

Reasons for withdrawal
Measure	Arepanrix 2D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 2D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Overall Study Adverse Event	1	1	1	1	0	0
Overall Study Lost to Follow-up	13	22	15	17	10	24
Overall Study Migrated/moved from study area	1	6	6	8	7	3
Overall Study Refused blood sampling	0	0	0	0	0	1
Overall Study Data not reliable	1	0	0	0	0	1
Overall Study Unable to attend visit(s)	2	4	2	1	3	2
Overall Study Consent not received from both parents	0	0	0	0	0	1
Overall Study Failure to comply with protocol	0	0	2	0	0	0
Overall Study Subject lost legal representation	0	0	0	0	1	0
Overall Study Protocol Violation	0	0	0	1	2	1
Overall Study Withdrawal by Subject	16	30	13	28	12	34

Baseline Characteristics

Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arepanrix 2D 6M-3Y Group n=610 Participants Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 2D 3Y-10Y Group n=1438 Participants Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6M-3Y Group n=612 Participants Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-10Y Group n=1436 Participants Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group n=613 Participants Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-10Y Group n=1436 Participants Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Total n=6145 Participants Total of all reporting groups
Age, Continuous	21.0 Months STANDARD_DEVIATION 8.8 • n=99 Participants	73.4 Months STANDARD_DEVIATION 23.8 • n=107 Participants	21.2 Months STANDARD_DEVIATION 8.8 • n=206 Participants	73.2 Months STANDARD_DEVIATION 24.2 • n=7 Participants	21.2 Months STANDARD_DEVIATION 8.6 • n=31 Participants	73.2 Months STANDARD_DEVIATION 24.3 • n=30 Participants	57.7 Months STANDARD_DEVIATION 31.6 • n=3 Participants
Sex: Female, Male Female	291 Participants n=99 Participants	688 Participants n=107 Participants	308 Participants n=206 Participants	748 Participants n=7 Participants	291 Participants n=31 Participants	732 Participants n=30 Participants	3058 Participants n=3 Participants
Sex: Female, Male Male	319 Participants n=99 Participants	750 Participants n=107 Participants	304 Participants n=206 Participants	688 Participants n=7 Participants	322 Participants n=31 Participants	704 Participants n=30 Participants	3087 Participants n=3 Participants
Race/Ethnicity, Customized African Heritage/African American	8 Participants n=99 Participants	22 Participants n=107 Participants	4 Participants n=206 Participants	22 Participants n=7 Participants	3 Participants n=31 Participants	26 Participants n=30 Participants	85 Participants n=3 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	2 Participants n=30 Participants	4 Participants n=3 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	1 Participants n=31 Participants	7 Participants n=30 Participants	12 Participants n=3 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	1 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants	0 Participants n=31 Participants	2 Participants n=30 Participants	8 Participants n=3 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	297 Participants n=99 Participants	507 Participants n=107 Participants	301 Participants n=206 Participants	503 Participants n=7 Participants	297 Participants n=31 Participants	499 Participants n=30 Participants	2404 Participants n=3 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific islander	0 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	4 Participants n=3 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Race/Ethnicity, Customized White-Caucasian/European Heritage	68 Participants n=99 Participants	172 Participants n=107 Participants	59 Participants n=206 Participants	161 Participants n=7 Participants	68 Participants n=31 Participants	165 Participants n=30 Participants	693 Participants n=3 Participants
Race/Ethnicity, Customized Other	235 Participants n=99 Participants	731 Participants n=107 Participants	246 Participants n=206 Participants	745 Participants n=7 Participants	243 Participants n=31 Participants	734 Participants n=30 Participants	2934 Participants n=3 Participants

PRIMARY outcome

Timeframe: From 14 days after first vaccination until study conclusion on Day 385

Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.

The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting at Least One A/California Influenza Event	3 Participants	7 Participants	13 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 42 days after first vaccination until study conclusion on Day 385

The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting at Least One A/California Influenza Event	3 Participants	5 Participants	9 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 until study conclusion on Day 385

The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting at Least One A/California Influenza Event	4 Participants	9 Participants	13 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 14 days after first vaccination until study conclusion on Day 385

The influenza virus presence was confirmed by a positive culture.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event	2 Participants	6 Participants	8 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 42 days after first vaccination until study conclusion on Day 385

The influenza virus presence was confirmed by a positive culture.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event	2 Participants	4 Participants	5 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 until study conclusion on Day 385

The influenza virus presence was confirmed by a positive culture.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event	3 Participants	7 Participants	8 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 14 days after first vaccination until study conclusion on Day 385

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With at Least One Pneumonia Event	16 Participants	13 Participants	20 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 42 days after first vaccination until study conclusion on Day 385

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With at Least One Pneumonia Event	16 Participants	12 Participants	18 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 after first vaccination until study conclusion on Day 385

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With at Least One Pneumonia Event	16 Participants	15 Participants	22 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 14 days after first vaccination until study conclusion at Day 385

Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With at Least One Pneumonia Event	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From 42 days after first vaccination until study conclusion at Day 385

Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With at Least One Pneumonia Event	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 after first vaccination until study conclusion at Day 385

Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1940 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1933 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1930 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With at Least One Pneumonia Event	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 until study end at Day 385

Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1903 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1913 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1897 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Fever	745 Participants	685 Participants	700 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Muscle aches all over body	271 Participants	219 Participants	239 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Cough	668 Participants	626 Participants	634 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Sore throat	395 Participants	362 Participants	379 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Runny or stuffy nose	682 Participants	628 Participants	649 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Short of breath	236 Participants	227 Participants	352 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Headache	360 Participants	340 Participants	422 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Vomiting	311 Participants	265 Participants	301 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Diarrhea	132 Participants	141 Participants	160 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Chills	282 Participants	265 Participants	272 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Fatigue	347 Participants	314 Participants	326 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 14 until study end at Day 385

Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1903 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1913 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1897 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Fever	716 Participants	659 Participants	677 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Muscle aches all over body	264 Participants	210 Participants	227 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Cough	643 Participants	599 Participants	614 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Sore throat	382 Participants	351 Participants	360 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Runny or stuffy nose	656 Participants	605 Participants	627 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Short of breath	225 Participants	218 Participants	214 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Headache	348 Participants	329 Participants	344 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Vomiting	302 Participants	254 Participants	291 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Diarrhea	124 Participants	137 Participants	157 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Chills	278 Participants	255 Participants	266 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases Fatigue	340 Participants	302 Participants	314 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 until study end at Day 385

Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1903 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1913 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1897 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Fever	4 Participants	7 Participants	11 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Muscle aches all over body	0 Participants	2 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Cough	4 Participants	7 Participants	11 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Sore throat	1 Participants	3 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Runny or stuffy nose	4 Participants	7 Participants	10 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Short of breath	1 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Headache	0 Participants	5 Participants	7 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Vomiting	2 Participants	2 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Diarrhea	1 Participants	3 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Chills	2 Participants	3 Participants	5 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Fatigue	2 Participants	4 Participants	4 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 14 until study end at Day 385

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=1903 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=1913 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=1897 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Sore throat	0 Participants	3 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Runny or stuffy nose	3 Participants	6 Participants	10 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Short of breath	1 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Headache	0 Participants	4 Participants	7 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Vomiting	2 Participants	2 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Diarrhea	1 Participants	3 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Chills	2 Participants	3 Participants	5 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Fatigue	2 Participants	3 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Fever	3 Participants	6 Participants	11 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Muscle aches all over body	0 Participants	2 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases Cough	3 Participants	6 Participants	11 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=610 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=726 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=712 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=612 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=744 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=692 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group n=613 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group n=714 Participants Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group n=722 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	288 Participants	454 Participants	487 Participants	222 Participants	382 Participants	431 Participants	154 Participants	258 Participants	322 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	204 Participants	369 Participants	416 Participants	189 Participants	357 Participants	409 Participants	122 Participants	212 Participants	254 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	13 Participants	16 Participants	16 Participants	13 Participants	24 Participants	25 Participants	5 Participants	7 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	8 Participants	9 Participants	13 Participants	8 Participants	8 Participants	18 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	11 Participants	30 Participants	25 Participants	17 Participants	16 Participants	30 Participants	2 Participants	10 Participants	13 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	213 Participants	344 Participants	347 Participants	104 Participants	153 Participants	133 Participants	86 Participants	157 Participants	213 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	14 Participants	24 Participants	23 Participants	5 Participants	5 Participants	5 Participants	5 Participants	6 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	12 Participants	7 Participants	17 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	24 Participants	19 Participants	21 Participants	1 Participants	4 Participants	4 Participants	2 Participants	8 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	24 Participants	39 Participants	34 Participants	16 Participants	28 Participants	27 Participants	10 Participants	11 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	20 Participants	16 Participants	25 Participants	8 Participants	8 Participants	18 Participants	2 Participants	2 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	31 Participants	42 Participants	38 Participants	17 Participants	17 Participants	32 Participants	3 Participants	16 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness which prevented normal everyday activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=610 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=726 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=612 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=744 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=613 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=714 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Irritability, Across doses	237 Participants	160 Participants	164 Participants	139 Participants	190 Participants	95 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Irritability, Dose 2	164 Participants	95 Participants	81 Participants	63 Participants	104 Participants	48 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Loss of appetite, Dose 2	112 Participants	96 Participants	61 Participants	67 Participants	102 Participants	53 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Irritability, Dose 2	9 Participants	2 Participants	2 Participants	2 Participants	6 Participants	2 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Irritability, Dose 2	114 Participants	72 Participants	44 Participants	46 Participants	64 Participants	34 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Loss of appetite, Dose 2	10 Participants	2 Participants	7 Participants	2 Participants	6 Participants	2 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Loss of appetite, Dose 2	73 Participants	56 Participants	27 Participants	49 Participants	62 Participants	34 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Temperature, Dose 2	148 Participants	99 Participants	44 Participants	47 Participants	56 Participants	31 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Temperature, Dose 2	29 Participants	11 Participants	12 Participants	10 Participants	14 Participants	4 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Temperature, Dose 2	113 Participants	74 Participants	22 Participants	27 Participants	28 Participants	19 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Drowsiness, Across doses	175 Participants	160 Participants	124 Participants	137 Participants	149 Participants	133 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Drowsiness, Across doses	15 Participants	10 Participants	6 Participants	4 Participants	8 Participants	6 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Drowsiness, Across doses	120 Participants	116 Participants	71 Participants	97 Participants	92 Participants	89 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Irritability, Across doses	14 Participants	5 Participants	5 Participants	3 Participants	8 Participants	2 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Irritability, Across doses	163 Participants	120 Participants	104 Participants	109 Participants	121 Participants	66 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Loss of appetite, Across doses	182 Participants	170 Participants	126 Participants	134 Participants	175 Participants	115 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Loss of appetite, Across doses	16 Participants	7 Participants	12 Participants	6 Participants	14 Participants	7 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Loss of appetite, Across doses	122 Participants	109 Participants	71 Participants	94 Participants	109 Participants	69 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Temperature, Across doses	198 Participants	145 Participants	124 Participants	97 Participants	97 Participants	59 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Temperature, Across doses	47 Participants	18 Participants	33 Participants	25 Participants	30 Participants	6 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Temperature, Across doses	143 Participants	107 Participants	83 Participants	62 Participants	51 Participants	34 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Drowsiness, Dose 1	105 Participants	103 Participants	93 Participants	112 Participants	106 Participants	101 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Drowsiness, Dose 1	7 Participants	7 Participants	3 Participants	1 Participants	3 Participants	5 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Drowsiness, Dose 1	62 Participants	70 Participants	50 Participants	74 Participants	56 Participants	62 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Irritability, Dose 1	149 Participants	99 Participants	128 Participants	111 Participants	135 Participants	67 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Irritability, Dose 1	5 Participants	3 Participants	3 Participants	1 Participants	2 Participants	1 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Loss of appetite, Dose 1	109 Participants	106 Participants	89 Participants	97 Participants	116 Participants	82 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Irritability, Dose 1	97 Participants	70 Participants	82 Participants	80 Participants	83 Participants	43 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Loss of appetite, Dose 1	7 Participants	5 Participants	5 Participants	4 Participants	8 Participants	5 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Loss of appetite, Dose 1	68 Participants	64 Participants	51 Participants	63 Participants	63 Participants	45 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Temperature, Dose 1	77 Participants	59 Participants	88 Participants	55 Participants	45 Participants	33 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Temperature, Dose 1	18 Participants	7 Participants	21 Participants	15 Participants	18 Participants	3 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Temperature, Dose 1	45 Participants	40 Participants	63 Participants	39 Participants	25 Participants	16 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Any Drowsiness, Dose 2	115 Participants	92 Participants	53 Participants	58 Participants	73 Participants	59 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Grade 3 Drowsiness, Dose 2	8 Participants	3 Participants	3 Participants	3 Participants	6 Participants	1 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years Related Drowsiness, Dose 2	81 Participants	65 Participants	32 Participants	42 Participants	52 Participants	41 Participants	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (gastro.sympt.), headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = Incidence of a particular symptom regardless of intensity grade or relationship to study vaccination. Grade 3 = symptom which prevented normal everyday activity. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=712 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=692 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=722 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Fatigue, Dose 2	89 Participants	51 Participants	48 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Muscle aches, Across doses	11 Participants	9 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Headache, Dose 2	105 Participants	48 Participants	45 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Joint pain at other location, Dose 2	61 Participants	35 Participants	23 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Joint pain at other location, Dose 2	5 Participants	3 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Joint pain at other location, Dose 2	42 Participants	28 Participants	13 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Muscle aches, Dose 2	105 Participants	48 Participants	46 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Muscle aches, Dose 2	7 Participants	3 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Muscle aches, Dose 2	82 Participants	41 Participants	35 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Shivering, Dose 2	34 Participants	15 Participants	10 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Shivering, Dose 2	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Shivering, Dose 2	22 Participants	10 Participants	7 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Sweating, Dose 2	36 Participants	15 Participants	20 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Sweating, Dose 2	3 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Sweating, Dose 2	25 Participants	6 Participants	8 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Temperature, Dose 2	61 Participants	16 Participants	19 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Temperature, Dose 2	14 Participants	5 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Temperature, Dose 2	42 Participants	5 Participants	11 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Fatigue, Across doses	139 Participants	118 Participants	106 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Fatigue, Across doses	14 Participants	5 Participants	7 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Fatigue, Across doses	104 Participants	77 Participants	57 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Gastro.sympt., Across doses	7 Participants	5 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Gastro.sympt., Across doses	66 Participants	65 Participants	72 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Gastro.sympt., Across doses	42 Participants	41 Participants	28 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Headache, Across doses	231 Participants	170 Participants	158 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Headache, Across doses	16 Participants	6 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Headache, Across doses	168 Participants	115 Participants	95 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Joint pain at other location, Across doses	102 Participants	92 Participants	61 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Joint pain at other location, Across doses	7 Participants	5 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Joint pain at other location, Across doses	73 Participants	67 Participants	37 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Muscle aches, Across doses	165 Participants	140 Participants	98 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Muscle aches, Across doses	131 Participants	107 Participants	68 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Shivering, Across doses	56 Participants	42 Participants	27 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Shivering, Across doses	3 Participants	3 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Shivering, Across doses	38 Participants	27 Participants	12 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Sweating, Across doses	51 Participants	41 Participants	44 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Sweating, Across doses	5 Participants	2 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Sweating, Across doses	36 Participants	20 Participants	17 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Temperature, Across doses	89 Participants	44 Participants	37 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Temperature, Across doses	21 Participants	13 Participants	7 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Temperature, Across doses	63 Participants	22 Participants	19 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Headache, Dose 1	103 Participants	87 Participants	63 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Fatigue, Dose 1	90 Participants	82 Participants	81 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Fatigue, Dose 1	6 Participants	4 Participants	5 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Fatigue, Dose 1	65 Participants	52 Participants	42 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Gastro.sympt., Dose 1	41 Participants	45 Participants	49 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Gastro.sympt., Dose 1	5 Participants	2 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Gastro.sympt., Dose 1	22 Participants	27 Participants	15 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Headache, Dose 1	141 Participants	129 Participants	108 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Headache, Dose 1	9 Participants	3 Participants	5 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Joint pain at other location, Dose 1	63 Participants	65 Participants	45 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Joint pain at other location, Dose 1	3 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Joint pain at other location, Dose 1	46 Participants	43 Participants	28 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Muscle aches, Dose 1	105 Participants	116 Participants	67 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Muscle aches, Dose 1	5 Participants	6 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Muscle aches, Dose 1	81 Participants	84 Participants	44 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Shivering, Dose 1	28 Participants	31 Participants	18 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Shivering, Dose 1	2 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Shivering, Dose 1	21 Participants	19 Participants	6 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Sweating, Dose 1	27 Participants	29 Participants	33 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Sweating, Dose 1	2 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Sweating, Dose 1	18 Participants	14 Participants	13 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Temperature, Dose 1	34 Participants	32 Participants	21 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Temperature, Dose 1	7 Participants	8 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Temperature, Dose 1	26 Participants	19 Participants	10 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Fatigue, Dose 2	10 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Fatigue, Dose 2	68 Participants	37 Participants	26 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Gastro.sympt., Dose 2	34 Participants	28 Participants	33 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Gastro.sympt., Dose 2	2 Participants	3 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Related Gastro.sympt., Dose 2	23 Participants	19 Participants	17 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Any Headache, Dose 2	148 Participants	75 Participants	75 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years Grade 3 Headache, Dose 2	9 Participants	3 Participants	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 385

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. This analysis compared the different treatment groups based on the type of vaccine received.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=2049 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)	0 Participants	2 Participants	3 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 385

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=2049 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any Medically-attended Adverse Events (MAEs)	1189 Participants	1173 Participants	1190 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 to Day 42

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=2049 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any Unsolicited Adverse Events (AEs)	913 Participants	904 Participants	895 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 385

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=2048 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=2049 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Serious Adverse Events (SAEs)	76 Participants	66 Participants	68 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 42

Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=233 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=167 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=232 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=156 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=223 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=164 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	12.40 Titers Interval 10.21 to 15.06	16.92 Titers Interval 13.77 to 20.8	11.19 Titers Interval 9.32 to 13.43	14.17 Titers Interval 11.48 to 17.49	12.25 Titers Interval 9.97 to 15.07	14.76 Titers Interval 12.04 to 18.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 42	1738.90 Titers Interval 1598.65 to 1891.44	1345.36 Titers Interval 1228.32 to 1473.55	258.02 Titers Interval 219.86 to 302.79	279.52 Titers Interval 229.58 to 340.31	188.89 Titers Interval 156.13 to 228.53	443.98 Titers Interval 367.03 to 537.04	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 42

A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=233 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=167 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=232 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=156 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=223 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=164 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	66 Participants	82 Participants	62 Participants	69 Participants	60 Participants	73 Participants	—	—	—
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 42	233 Participants	167 Participants	232 Participants	156 Participants	220 Participants	163 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoints.

Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=229 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=166 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=228 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=153 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=220 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=161 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain	228 Participants	166 Participants	224 Participants	149 Participants	187 Participants	155 Participants	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 42

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=233 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=167 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=232 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=156 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=223 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=164 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	61 Participants	66 Participants	55 Participants	45 Participants	55 Participants	53 Participants	—	—	—
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 42	233 Participants	167 Participants	229 Participants	154 Participants	199 Participants	160 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 42

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=229 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=166 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=228 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=153 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=220 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=161 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain	140.8 Fold change Interval 116.6 to 170.0	79.9 Fold change Interval 65.3 to 97.6	23.4 Fold change Interval 21.2 to 25.7	20.3 Fold change Interval 17.7 to 23.3	15.6 Fold change Interval 13.5 to 18.0	29.9 Fold change Interval 25.1 to 35.7	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint. The groups were pooled, based on the type of vaccine received and regardless the age strata.

The geometric mean titer ratio (GMT ratio) was defined as the ratio of geometric mean of the post-vaccination reciprocal HI titer between groups. The analysis was not performed for Day 182 and Day 385 as planned per protocol.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=381 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=395 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=381 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)	278.9 Adjusted GMT ratio	1548.5 Adjusted GMT ratio	275.8 Adjusted GMT ratio	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=186 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=378 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=177 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=389 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=184 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=379 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Day 0	12.62 Titers Interval 8.79 to 18.12	11.79 Titers Interval 7.9 to 17.6	9.77 Titers Interval 7.23 to 13.22	17.57 Titers Interval 12.16 to 25.4	14.22 Titers Interval 9.03 to 22.4	12.19 Titers Interval 8.43 to 17.63	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Day 182	287.22 Titers Interval 246.77 to 334.29	238.25 Titers Interval 213.25 to 266.18	76.52 Titers Interval 61.99 to 94.46	108.59 Titers Interval 94.1 to 125.3	74.94 Titers Interval 59.09 to 95.05	145.06 Titers Interval 128.28 to 164.03	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=186 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=378 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=177 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=389 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=184 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=379 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	20 Participants	15 Participants	17 Participants	29 Participants	17 Participants	18 Participants	—	—	—
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 182	186 Participants	378 Participants	177 Participants	384 Participants	174 Participants	377 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=70 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=40 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=75 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=51 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=61 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=49 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain	66 Participants	38 Participants	54 Participants	33 Participants	32 Participants	34 Participants	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=186 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=378 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=177 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=389 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=184 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=379 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	19 Participants	10 Participants	16 Participants	17 Participants	17 Participants	14 Participants	—	—	—
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 182	184 Participants	374 Participants	120 Participants	288 Participants	117 Participants	337 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 182

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=70 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=40 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=75 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=51 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=61 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=49 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain	24.0 Fold change Interval 18.5 to 31.1	18.4 Fold change Interval 13.1 to 25.8	8.0 Fold change Interval 6.8 to 9.3	6.1 Fold change Interval 4.7 to 7.9	4.8 Fold change Interval 3.7 to 6.3	8.5 Fold change Interval 6.4 to 11.4	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 385

Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=173 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=349 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=163 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=339 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=158 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=344 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	9.62 Titers Interval 6.76 to 13.69	15.71 Titers Interval 9.76 to 25.27	9.93 Titers Interval 6.71 to 14.71	14.92 Titers Interval 8.99 to 24.74	10.13 Titers Interval 7.04 to 14.56	13.57 Titers Interval 8.5 to 21.66	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 385	265.61 Titers Interval 228.92 to 308.18	189.44 Titers Interval 169.64 to 211.55	112.56 Titers Interval 91.27 to 138.81	103.57 Titers Interval 89.9 to 119.32	54.90 Titers Interval 42.15 to 71.5	92.33 Titers Interval 80.18 to 106.31	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 385

A seropositive subject was defined as a subject whose HI titers was greater than or equal to (≥) 1:10.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=173 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=349 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=163 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=339 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=158 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=344 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	12 Participants	16 Participants	11 Participants	14 Participants	14 Participants	14 Participants	—	—	—
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 385	173 Participants	349 Participants	163 Participants	334 Participants	142 Participants	333 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 385

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=62 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=33 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=51 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=32 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=55 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=34 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain	58 Participants	30 Participants	35 Participants	17 Participants	18 Participants	18 Participants	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 385

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=173 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=349 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=163 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=339 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=158 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=344 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 0	11 Participants	12 Participants	10 Participants	10 Participants	11 Participants	9 Participants	—	—	—
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain Day 385	169 Participants	339 Participants	128 Participants	266 Participants	82 Participants	259 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 385

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.

Outcome measures

Outcome measures
Measure	Arepanrix 2D Group n=62 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D Group n=33 Participants Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	GSK2340273A Group n=51 Participants Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.	Arepanrix 1D 6M-3Y Group n=32 Participants Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-6Y Group n=55 Participants Subjects, male and female, aged 3 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6Y-10Y Group n=34 Participants Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to less than (\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-6Y Group Subjects, male and female, aged 2 years (Y) to less than (\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6Y-10Y Group Subjects, male and female, aged 6 years (Y) to less than (\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain	26.6 Fold change Interval 20.0 to 35.3	13.7 Fold change Interval 9.9 to 19.0	8.5 Fold change Interval 6.5 to 11.0	6.3 Fold change Interval 4.2 to 9.4	3.7 Fold change Interval 2.8 to 4.7	6.1 Fold change Interval 4.2 to 8.7	—	—	—

Adverse Events

Arepanrix 2D 6M-3Y Group

Serious events: 35 serious events

Other events: 498 other events

Deaths: 1 deaths

Arepanrix 2D 3Y-10Y Group

Serious events: 41 serious events

Other events: 1116 other events

Deaths: 1 deaths

Arepanrix 1D 6M-3Y Group

Serious events: 29 serious events

Other events: 439 other events

Deaths: 1 deaths

Arepanrix 1D 3Y-10Y Group

Serious events: 37 serious events

Other events: 1047 other events

Deaths: 0 deaths

GSK2340273A 6M-3Y Group

Serious events: 33 serious events

Other events: 446 other events

Deaths: 0 deaths

GSK2340273A 3Y-10Y Group

Serious events: 35 serious events

Other events: 891 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arepanrix 2D 6M-3Y Group n=610 participants at risk Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 2D 3Y-10Y Group n=1438 participants at risk Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6M-3Y Group n=612 participants at risk Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-10Y Group n=1436 participants at risk Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group n=613 participants at risk Subjects, male and female, aged 6 months to 3 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-10Y Group n=1436 participants at risk Subjects, male and female, aged 3 years to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Musculoskeletal and connective tissue disorders Osteosclerosis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Eye disorders Conjunctivitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Abdominal pain	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Cheilitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Colitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Constipation	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Diarrhoea	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Enteritis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.49% 3/613 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Faecaloma	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Food poisoning	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Gastritis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.33% 2/613 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Ileus paralytic	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Inguinal hernia	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Intestinal obstruction	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Intussusception	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Peritoneal haemorrhage	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Rectal fissure	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Tongue disorder	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Vomiting	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Drowning	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Influenza like illness	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Pyrexia	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Hepatobiliary disorders Hepatitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Acute sinusitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Acute tonsillitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Adenoiditis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Amoebiasis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Appendicitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.35% 5/1438 • Number of events 5 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Ascariasis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Bronchiolitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Bronchitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.35% 5/1436 • Number of events 5 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Bronchopneumonia	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Carbuncle	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Cellulitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Conjunctivitis bacterial	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Dengue fever	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Gastritis viral	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Gastroenteritis	1.1% 7/610 • Number of events 8 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.21% 3/1438 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.1% 7/612 • Number of events 7 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.28% 4/1436 • Number of events 4 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.8% 11/613 • Number of events 11 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.42% 6/1436 • Number of events 6 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Gastroenteritis rotavirus	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Hepatitis a	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Hepatitis viral	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Infectious mononucleosis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Influenza	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Meningitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Meningitis viral	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Nasopharyngitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Oral herpes	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Otitis media	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Parasitic gastroenteritis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Periorbital cellulitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pharyngitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pharyngotonsillitis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pneumonia	0.98% 6/610 • Number of events 6 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.21% 3/1438 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.1% 7/612 • Number of events 8 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.6% 10/613 • Number of events 10 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pneumonia bacterial	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pneumonia parainfluenzae viral	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pneumonia viral	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pulmonary tuberculosis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Pyelonephritis	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Subcutaneous abscess	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Tonsillitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Tracheitis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Typhoid fever	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Upper respiratory tract infection	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Urinary tract infection	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.28% 4/1438 • Number of events 4 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Varicella	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Viral infection	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1438 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.21% 3/1436 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Concussion	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Contusion	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Eye injury	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Facial bones fracture	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Forearm fracture	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Foreign body	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Hip fracture	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Limb injury	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Mechanical ventilation complication	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Injury, poisoning and procedural complications Wound	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Metabolism and nutrition disorders Dehydration	0.33% 2/610 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Nervous system disorders Convulsion	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Nervous system disorders Extrapyramidal disorder	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Nervous system disorders Febrile convulsion	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.33% 2/612 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.33% 2/613 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Nervous system disorders Guillain-barre syndrome	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Renal and urinary disorders Glomerulonephritis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Renal and urinary disorders Renal failure acute	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Reproductive system and breast disorders Vaginal laceration	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Asthma	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1438 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.49% 3/612 • Number of events 3 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.16% 1/610 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.21% 3/1438 • Number of events 4 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.14% 2/1436 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/612 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.16% 1/610 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Skin and subcutaneous tissue disorders Urticaria chronic	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Social circumstances Sexual abuse	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Vascular disorders Extremity necrosis	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1438 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Vascular disorders Subgaleal haematoma	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1438 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.07% 1/1436 • Number of events 1 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/1436 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).

Other adverse events

Other adverse events
Measure	Arepanrix 2D 6M-3Y Group n=610 participants at risk Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 2D 3Y-10Y Group n=1438 participants at risk Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	Arepanrix 1D 6M-3Y Group n=612 participants at risk Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	Arepanrix 1D 3Y-10Y Group n=1436 participants at risk Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).	GSK2340273A 6M-3Y Group n=613 participants at risk Subjects, male and female, aged 6 months to 3 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.	GSK2340273A 3Y-10Y Group n=1436 participants at risk Subjects, male and female, aged 3 years to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	7.2% 103/1438 • Number of events 125 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	6.4% 92/1436 • Number of events 101 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.16% 1/613 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	4.2% 61/1436 • Number of events 69 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Metabolism and nutrition disorders Decreased appetite	29.8% 182/610 • Number of events 222 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	11.9% 171/1438 • Number of events 204 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	20.8% 127/612 • Number of events 151 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.4% 135/1436 • Number of events 165 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	28.7% 176/613 • Number of events 219 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	8.0% 115/1436 • Number of events 136 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Fatigue	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.7% 140/1438 • Number of events 180 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	8.2% 118/1436 • Number of events 133 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	7.4% 106/1436 • Number of events 129 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	4.7% 68/1438 • Number of events 77 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.33% 2/612 • Number of events 2 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	4.6% 66/1436 • Number of events 74 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	5.1% 73/1436 • Number of events 83 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Nervous system disorders Headache	0.66% 4/610 • Number of events 4 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	17.7% 254/1438 • Number of events 321 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.65% 4/612 • Number of events 4 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	13.1% 188/1436 • Number of events 224 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	12.0% 172/1436 • Number of events 205 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Psychiatric disorders Irritability	38.9% 237/610 • Number of events 313 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	11.3% 162/1438 • Number of events 196 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	26.8% 164/612 • Number of events 209 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.8% 141/1436 • Number of events 176 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	31.0% 190/613 • Number of events 240 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	6.6% 95/1436 • Number of events 115 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/610 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	11.5% 166/1438 • Number of events 211 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/612 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.7% 140/1436 • Number of events 164 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.00% 0/613 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	7.0% 100/1436 • Number of events 115 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Pain	47.2% 288/610 • Number of events 417 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	65.4% 941/1438 • Number of events 1476 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	36.3% 222/612 • Number of events 294 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	56.6% 813/1436 • Number of events 1052 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	25.1% 154/613 • Number of events 208 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	40.4% 580/1436 • Number of events 836 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Pyrexia	37.7% 230/610 • Number of events 272 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	17.8% 256/1438 • Number of events 279 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	24.7% 151/612 • Number of events 166 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	11.7% 168/1436 • Number of events 186 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	20.9% 128/613 • Number of events 136 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	8.7% 125/1436 • Number of events 137 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Nervous system disorders Somnolence	28.7% 175/610 • Number of events 220 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	11.1% 160/1438 • Number of events 195 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	20.3% 124/612 • Number of events 146 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.7% 139/1436 • Number of events 172 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	24.3% 149/613 • Number of events 179 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.3% 134/1436 • Number of events 161 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
General disorders Swelling	5.1% 31/610 • Number of events 35 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	5.6% 80/1438 • Number of events 95 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	2.8% 17/612 • Number of events 18 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	3.4% 49/1436 • Number of events 54 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	0.49% 3/613 • Number of events 4 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	2.2% 31/1436 • Number of events 38 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Respiratory, thoracic and mediastinal disorders Cough	10.0% 61/610 • Number of events 67 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	6.1% 88/1438 • Number of events 100 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	7.7% 47/612 • Number of events 53 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	6.3% 91/1436 • Number of events 98 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.1% 56/613 • Number of events 60 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	7.1% 102/1436 • Number of events 111 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Gastrointestinal disorders Diarrohoea	5.4% 33/610 • Number of events 36 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.6% 23/1438 • Number of events 23 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	3.9% 24/612 • Number of events 26 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.9% 28/1436 • Number of events 28 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	4.6% 28/613 • Number of events 30 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	1.4% 20/1436 • Number of events 20 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Nasopharyngitis	16.2% 99/610 • Number of events 110 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	7.8% 112/1438 • Number of events 120 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	13.4% 82/612 • Number of events 90 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	8.0% 115/1436 • Number of events 126 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	16.0% 98/613 • Number of events 109 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	6.9% 99/1436 • Number of events 107 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Infections and infestations Upper respiratory tract infection	19.7% 120/610 • Number of events 135 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	9.2% 132/1438 • Number of events 148 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	19.4% 119/612 • Number of events 129 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	10.0% 144/1436 • Number of events 156 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	20.4% 125/613 • Number of events 147 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).	8.8% 127/1436 • Number of events 145 • Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).

Additional Information

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GlaxoSmithKline

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER