Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children (NCT NCT01198756)

NCT ID: NCT01198756

Last Updated: 2018-09-21

Results Overview

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3109 participants

Primary outcome timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Results posted on

2018-09-21

Participant Flow

A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.

Unprimed Subjects - subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season - received a 2-dose vaccination course. Primed Subjects - all other subjects - received a 1-dose vaccination course.

Participant milestones

Participant milestones
Measure	GSK2282512A 1 Group Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Overall Study STARTED	932	929	932	301
Overall Study COMPLETED	894	889	902	275
Overall Study NOT COMPLETED	38	40	30	26

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2282512A 1 Group Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Overall Study Adverse Event	0	0	0	1
Overall Study Protocol Violation	0	0	0	2
Overall Study Withdrawal by Subject	9	4	7	5
Overall Study Lost to Follow-up	29	36	23	18

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2282512A 1 Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=929 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=301 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Total n=3094 Participants Total of all reporting groups
Age, Continuous	8.9 Years STANDARD_DEVIATION 4.21 • n=5 Participants	8.9 Years STANDARD_DEVIATION 4.23 • n=7 Participants	8.9 Years STANDARD_DEVIATION 4.17 • n=5 Participants	1.2 Years STANDARD_DEVIATION 0.73 • n=4 Participants	8.1 Years STANDARD_DEVIATION 4.60 • n=21 Participants
Sex: Female, Male Female	434 Participants n=5 Participants	455 Participants n=7 Participants	464 Participants n=5 Participants	143 Participants n=4 Participants	1496 Participants n=21 Participants
Sex: Female, Male Male	498 Participants n=5 Participants	474 Participants n=7 Participants	468 Participants n=5 Participants	158 Participants n=4 Participants	1598 Participants n=21 Participants

PRIMARY outcome

Timeframe: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=878 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=871 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=878 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Yamagata, POST	512.5 titer Interval 477.6 to 549.9	197.0 titer Interval 180.7 to 214.8	579.0 titer Interval 541.2 to 619.3	192.7 titer Interval 172.1 to 215.7	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, POST	362.7 titer Interval 335.3 to 392.3	429.1 titer Interval 396.5 to 464.3	420.2 titer Interval 388.8 to 454.0	200.9 titer Interval 166.6 to 242.2	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N2, POST	143.7 titer Interval 134.2 to 153.9	139.6 titer Interval 130.5 to 149.3	151.0 titer Interval 141.0 to 161.6	61.4 titer Interval 53.8 to 70.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Victoria, POST	250.5 titer Interval 230.8 to 272.0	245.4 titer Interval 226.9 to 265.4	68.1 titer Interval 61.9 to 74.9	127.3 titer Interval 109.4 to 148.1	—	—	—

PRIMARY outcome

Timeframe: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=876 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=870 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=877 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease H1N1, POST	739 Participants	755 Participants	750 Participants	220 Participants	—	—	—
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease H3N2, POST	614 Participants	590 Participants	610 Participants	189 Participants	—	—	—
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease Victoria, POST	653 Participants	622 Participants	262 Participants	219 Participants	—	—	—
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease Yamagata, POST	659 Participants	359 Participants	644 Participants	243 Participants	—	—	—

SECONDARY outcome

Timeframe: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=878 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=871 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=878 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, Day 0	29.4 titer Interval 26.8 to 32.2	32.2 titer Interval 29.4 to 35.3	29.1 titer Interval 26.6 to 31.8	16.8 titer Interval 13.9 to 20.3	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, POST	362.7 titer Interval 335.3 to 392.3	429.1 titer Interval 396.5 to 464.3	420.2 titer Interval 388.8 to 454.0	200.9 titer Interval 166.6 to 242.2	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N2, Day 0	18.1 titer Interval 16.7 to 19.7	19.0 titer Interval 17.4 to 20.6	19.4 titer Interval 17.8 to 21.1	5.6 titer Interval 5.3 to 6.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N2, POST	143.7 titer Interval 134.2 to 153.9	139.6 titer Interval 130.5 to 149.3	151.0 titer Interval 141.0 to 161.6	61.4 titer Interval 53.8 to 70.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Victoria, Day 0	24.8 titer Interval 22.5 to 27.3	25.8 titer Interval 23.5 to 28.4	25.8 titer Interval 23.5 to 28.4	8.7 titer Interval 7.5 to 10.0	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Victoria, POST	250.5 titer Interval 230.8 to 272.0	245.4 titer Interval 226.9 to 265.4	68.1 titer Interval 61.9 to 74.9	127.3 titer Interval 109.4 to 148.1	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Yamagata, Day 0	57.9 titer Interval 52.0 to 64.4	58.4 titer Interval 52.6 to 64.9	65.9 titer Interval 59.3 to 73.2	7.7 titer Interval 7.0 to 8.6	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Yamagata, POST	512.5 titer Interval 477.6 to 549.9	197.0 titer Interval 180.7 to 214.8	579.0 titer Interval 541.2 to 619.3	192.7 titer Interval 172.1 to 215.7	—	—	—

SECONDARY outcome

Timeframe: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=878 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=871 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=878 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease H1N1, Day 0	480 Participants	496 Participants	477 Participants	87 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease H1N1, POST	850 Participants	848 Participants	848 Participants	232 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease H3N2, Day 0	295 Participants	301 Participants	324 Participants	7 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease H3N2, POST	816 Participants	808 Participants	819 Participants	193 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease Victoria, Day 0	388 Participants	404 Participants	400 Participants	28 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease Victoria, POST	838 Participants	839 Participants	643 Participants	228 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease Yamagata, Day 0	578 Participants	583 Participants	622 Participants	22 Participants	—	—	—
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease Yamagata, POST	869 Participants	805 Participants	873 Participants	250 Participants	—	—	—

SECONDARY outcome

Timeframe: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=876 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=870 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=877 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H1N1, POST	12.31 fold change Interval 11.34 to 13.35	13.31 fold change Interval 12.28 to 14.43	14.42 fold change Interval 13.27 to 15.66	11.95 fold change Interval 10.52 to 13.59	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease H3N2, POST	7.94 fold change Interval 7.3 to 8.64	7.37 fold change Interval 6.78 to 8.02	7.78 fold change Interval 7.16 to 8.46	10.94 fold change Interval 9.64 to 12.42	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Victoria, POST	10.12 fold change Interval 9.23 to 11.09	9.51 fold change Interval 8.64 to 10.45	2.63 fold change Interval 2.47 to 2.81	14.61 fold change Interval 12.84 to 16.63	—	—	—
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease Yamagata, POST	8.86 fold change Interval 8.12 to 9.66	3.37 fold change Interval 3.14 to 3.62	8.78 fold change Interval 8.05 to 9.58	24.92 fold change Interval 21.98 to 28.26	—	—	—

SECONDARY outcome

Timeframe: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=425 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=453 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=424 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=447 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group n=424 Participants Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group n=454 Participants Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata H1N1, Day 0	24.7 titer Interval 21.6 to 28.3	34.6 titer Interval 30.6 to 39.2	26.9 titer Interval 23.5 to 30.9	38.2 titer Interval 33.8 to 43.1	24.5 titer Interval 21.5 to 27.8	34.2 titer Interval 30.3 to 38.6	16.8 titer Interval 13.9 to 20.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata H1N1, POST	310.5 titer Interval 274.9 to 350.6	419.5 titer Interval 379.8 to 463.4	382.7 titer Interval 339.4 to 431.6	478.2 titer Interval 431.4 to 530.0	356.2 titer Interval 316.5 to 400.8	490.3 titer Interval 443.7 to 541.7	200.9 titer Interval 166.6 to 242.2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata H3N2, Day 0	19.7 titer Interval 17.4 to 22.4	16.7 titer Interval 15.0 to 18.7	21.2 titer Interval 18.6 to 24.2	17.0 titer Interval 15.3 to 19.0	20.2 titer Interval 17.8 to 23.0	18.6 titer Interval 16.6 to 20.9	5.6 titer Interval 5.3 to 6.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata H3N2, POST	138.2 titer Interval 123.7 to 154.5	149.1 titer Interval 137.3 to 162.0	144.4 titer Interval 130.6 to 159.7	135.2 titer Interval 123.5 to 148.0	147.9 titer Interval 133.3 to 164.1	153.9 titer Interval 140.7 to 168.4	61.4 titer Interval 53.8 to 70.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata Victoria, Day 0	18.3 titer Interval 15.8 to 21.1	32.9 titer Interval 29.0 to 37.4	20.2 titer Interval 17.6 to 23.3	32.5 titer Interval 28.7 to 36.8	18.4 titer Interval 16.0 to 21.1	35.4 titer Interval 31.3 to 40.1	8.7 titer Interval 7.5 to 10.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata Victoria, POST	194.4 titer Interval 171.3 to 220.7	317.8 titer Interval 287.1 to 351.8	197.4 titer Interval 175.9 to 221.6	301.7 titer Interval 272.2 to 334.3	52.6 titer Interval 45.2 to 61.2	86.6 titer Interval 77.4 to 96.9	127.3 titer Interval 109.4 to 148.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata Yamagata, Day 0	27.4 titer Interval 23.8 to 31.7	116.2 titer Interval 102.2 to 132.1	29.5 titer Interval 25.6 to 34.0	111.6 titer Interval 98.3 to 126.8	29.5 titer Interval 25.5 to 34.1	139.6 titer Interval 124.6 to 156.4	7.7 titer Interval 7.0 to 8.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata Yamagata, POST	363.4 titer Interval 327.8 to 402.9	707.5 titer Interval 648.7 to 771.5	103.2 titer Interval 91.7 to 116.1	363.7 titer Interval 330.4 to 400.3	416.7 titer Interval 374.5 to 463.7	787.1 titer Interval 731.3 to 847.2	192.7 titer Interval 172.1 to 215.7

SECONDARY outcome

Timeframe: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=423 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=453 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=423 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=447 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group n=424 Participants Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group n=453 Participants Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata Yamagata, POST	366 Participants	293 Participants	181 Participants	178 Participants	372 Participants	272 Participants	243 Participants
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata H1N1, POST	374 Participants	365 Participants	390 Participants	365 Participants	380 Participants	370 Participants	220 Participants
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata H3N2, POST	291 Participants	323 Participants	282 Participants	308 Participants	296 Participants	314 Participants	189 Participants
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata Victoria, POST	329 Participants	324 Participants	326 Participants	296 Participants	133 Participants	129 Participants	219 Participants

SECONDARY outcome

Timeframe: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=425 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=453 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=424 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=447 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group n=424 Participants Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group n=454 Participants Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata Yamagata, POST	419 Participants	450 Participants	361 Participants	444 Participants	420 Participants	453 Participants	250 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata H1N1, Day 0	209 Participants	271 Participants	218 Participants	278 Participants	207 Participants	270 Participants	87 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata H1N1, POST	405 Participants	445 Participants	412 Participants	436 Participants	405 Participants	443 Participants	232 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata H3N2, Day 0	161 Participants	134 Participants	174 Participants	127 Participants	168 Participants	156 Participants	7 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata H3N2, POST	379 Participants	437 Participants	390 Participants	418 Participants	389 Participants	430 Participants	193 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata Victoria, Day 0	144 Participants	244 Participants	163 Participants	241 Participants	150 Participants	250 Participants	28 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata Victoria, POST	398 Participants	440 Participants	406 Participants	433 Participants	271 Participants	372 Participants	228 Participants
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata Yamagata, Day 0	205 Participants	373 Participants	209 Participants	374 Participants	220 Participants	402 Participants	22 Participants

SECONDARY outcome

Timeframe: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

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 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=423 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=453 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=423 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=447 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group n=424 Participants Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group n=453 Participants Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=259 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata H1N1, POST	12.50 fold change Interval 11.31 to 13.82	12.12 fold change Interval 10.67 to 13.77	14.20 fold change Interval 12.83 to 15.71	12.52 fold change Interval 11.07 to 14.17	14.56 fold change Interval 13.2 to 16.05	14.29 fold change Interval 12.52 to 16.31	11.95 fold change Interval 10.52 to 13.59
Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata H3N2, POST	7.02 fold change Interval 6.3 to 7.84	8.91 fold change Interval 7.85 to 10.11	6.82 fold change Interval 6.09 to 7.64	7.94 fold change Interval 7.02 to 8.97	7.29 fold change Interval 6.51 to 8.16	8.27 fold change Interval 7.32 to 9.34	10.94 fold change Interval 9.64 to 12.42
Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata Victoria, POST	10.64 fold change Interval 9.41 to 12.02	9.65 fold change Interval 8.42 to 11.07	9.75 fold change Interval 8.61 to 11.04	9.28 fold change Interval 8.04 to 10.71	2.85 fold change Interval 2.58 to 3.16	2.44 fold change Interval 2.25 to 2.65	14.61 fold change Interval 12.84 to 16.63
Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata Yamagata, POST	13.23 fold change Interval 11.74 to 14.9	6.09 fold change Interval 5.42 to 6.84	3.49 fold change Interval 3.18 to 3.84	3.26 fold change Interval 2.93 to 3.62	14.11 fold change Interval 12.57 to 15.84	5.63 fold change Interval 5.02 to 6.33	24.92 fold change Interval 21.98 to 28.26

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects \< 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=913 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=912 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=916 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=294 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any pain	637 Participants	538 Participants	542 Participants	148 Participants	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 pain	35 Participants	21 Participants	26 Participants	6 Participants	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any redness	57 Participants	38 Participants	36 Participants	24 Participants	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 redness	1 Participants	0 Participants	0 Participants	2 Participants	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any swelling	64 Participants	40 Participants	39 Participants	18 Participants	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 swelling	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=597 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=497 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=510 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=131 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Days With Solicited Local Symptoms After Vaccination Redness, Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 3.0	2.5 Days Interval 1.0 to 4.0	—	—	—
Number of Days With Solicited Local Symptoms After Vaccination Swelling, Dose 2	2.5 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	3.0 Days Interval 2.0 to 4.0	—	—	—
Number of Days With Solicited Local Symptoms After Vaccination Pain, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	—	—	—
Number of Days With Solicited Local Symptoms After Vaccination Pain, Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—	—
Number of Days With Solicited Local Symptoms After Vaccination Redness, Dose 1	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 5.0	—	—	—
Number of Days With Solicited Local Symptoms After Vaccination Swelling, Dose 1	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 3.0	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=185 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=187 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=189 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=292 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Any drowsiness	46 Participants	47 Participants	51 Participants	102 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Grade 3 drowsiness	0 Participants	3 Participants	1 Participants	7 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Related drowsiness	34 Participants	40 Participants	42 Participants	93 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Any irritability	59 Participants	44 Participants	48 Participants	141 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Grade 3 irritability	3 Participants	0 Participants	3 Participants	14 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Related irritability	45 Participants	36 Participants	45 Participants	130 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Any loss of appetite	40 Participants	41 Participants	35 Participants	93 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Grade 3 loss of appetite	0 Participants	6 Participants	3 Participants	5 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Related loss of appetite	21 Participants	28 Participants	24 Participants	73 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Any temperature	15 Participants	16 Participants	15 Participants	27 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Grade 3 temperature	3 Participants	5 Participants	5 Participants	6 Participants	—	—	—
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms Related temperature	6 Participants	10 Participants	6 Participants	18 Participants	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=727 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=725 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=726 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 muscle aches	6 Participants	5 Participants	9 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any fatigue	173 Participants	177 Participants	177 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue	6 Participants	13 Participants	8 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related fatigue	143 Participants	149 Participants	134 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal symptoms	80 Participants	82 Participants	72 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal symptoms	9 Participants	8 Participants	6 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal symptoms	55 Participants	51 Participants	37 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any headache	170 Participants	171 Participants	157 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache	8 Participants	9 Participants	10 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related headache	134 Participants	134 Participants	116 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any joint pain at other location	103 Participants	95 Participants	81 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 joint pain at other location	4 Participants	5 Participants	1 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related joint pain at other location	82 Participants	80 Participants	67 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any muscle aches	222 Participants	194 Participants	193 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related muscle aches	202 Participants	178 Participants	170 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any shivering	55 Participants	51 Participants	53 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering	4 Participants	10 Participants	4 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related shivering	45 Participants	35 Participants	41 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Any temperature	26 Participants	33 Participants	20 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Grade 3 temperature	5 Participants	8 Participants	2 Participants	—	—	—	—
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms Related temperature	16 Participants	18 Participants	13 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=48 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=37 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=44 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=120 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age Loss of appetite, Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age Drowsiness, Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age Drowsiness, Dose 2	1.0 Days Interval 1.0 to 1.5	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age Irritability, Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age Irritability, Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.5	2.0 Days Interval 1.0 to 3.0	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age Loss of appetite, Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	3.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 3.0	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=207 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=180 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=179 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Fatigue, Dose 1	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Fatigue, Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Gastrointestinal symptoms, Dose 1	1.5 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Gastrointestinal symptoms, Dose 2	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Headache, Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Headache, Dose 2	1.5 Days Interval 1.0 to 2.5	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Joint pain at other location, Dose 1	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 3.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Joint pain at other location, Dose 2	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Muscle aches, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Muscle aches, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Shivering, Dose 1	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0	—	—	—	—
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above Shivering, Dose 2	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	2.0 Days Interval 1.0 to 2.0	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (Days 0-6) after vaccination

Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=25 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=43 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=26 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=16 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination Fever, Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.5	—	—	—
Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination Fever, Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	—	—	—

SECONDARY outcome

Timeframe: During the 28-day follow-up period (Day 0-27) after vaccination

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Unsolicited AE covers any AE 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 unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=929 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=301 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any unsolicited AE(s)	283 Participants	291 Participants	275 Participants	160 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 unsolicited AE(s)	40 Participants	41 Participants	35 Participants	24 Participants	—	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related unsolicited AE(s)	44 Participants	47 Participants	44 Participants	43 Participants	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 to Day 180)

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=929 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=301 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination Any pIMD(s)	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination Related pIMD(s)	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 to Day 180)

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=929 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=301 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination	346 Participants	335 Participants	350 Participants	147 Participants	—	—	—

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 to Day 180)

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A 1 Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Victoria Strain Fluarix Group n=929 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix Group n=932 Participants Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group n=301 Participants Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.	Yamagata Strain Fluarix (3-8 Years) Group Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Yamagata Strain Fluarix (9-17 Years) Group Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Related SAE(s)	0 Participants	0 Participants	1 Participants	2 Participants	—	—	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Any SAE(s)	3 Participants	6 Participants	5 Participants	7 Participants	—	—	—

Adverse Events

GSK2282512A 1 Group

Serious events: 3 serious events

Other events: 731 other events

Deaths: 0 deaths

Victoria Strain Fluarix Group

Serious events: 6 serious events

Other events: 666 other events

Deaths: 0 deaths

Yamagata Strain Fluarix Group

Serious events: 5 serious events

Other events: 659 other events

Deaths: 0 deaths

GSK2282512A 2 Group

Serious events: 7 serious events

Other events: 233 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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