Trial Outcomes & Findings for Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children (NCT NCT01001169)

Last Updated: 2018-08-17

Results Overview

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

At Day 42

Results posted on

2018-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	GSK2340274A_F1 6M-9Y Group Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F2 10Y-17Y Group Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Overall Study STARTED	30	30
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2340274A_F1 6M-9Y Group Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F2 10Y-17Y Group Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2340274A_F1 6M-9Y Group n=30 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	Total n=60 Participants Total of all reporting groups
Age, Continuous	49.00 Months STANDARD_DEVIATION 27.66 • n=5 Participants	163.00 Months STANDARD_DEVIATION 32.41 • n=7 Participants	106.00 Months STANDARD_DEVIATION 64.78 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value	30 Subjects	28 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	874.3 Titers Interval 717.4 to 1065.4	939.3 Titers Interval 722.9 to 1220.6	—	—

PRIMARY outcome

Timeframe: At Day 42

Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroconverted Subjects for HI Antibodies	30 Subjects	28 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 42

A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroprotected Subjects for HI Antibodies	30 Subjects	28 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 42

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	57.1 Titers Interval 33.5 to 97.3	146.8 Titers Interval 99.6 to 216.4	—	—

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=10 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 0	18 Subjects	5 Subjects	0 Subjects	5 Subjects
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 21	30 Subjects	29 Subjects	10 Subjects	19 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 42

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=19 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=9 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 0	5 Subjects	0 Subjects	—	—
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 42	19 Subjects	9 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=9 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 0	17 Subjects	5 Subjects	0 Subjects	5 Subjects
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Flu A/CAL/7/09, Day 182	29 Subjects	28 Subjects	9 Subjects	19 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=10 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 21	339.0 Titers Interval 238.8 to 481.2	172.0 Titers Interval 130.1 to 227.6	117.3 Titers Interval 72.2 to 190.8	210.4 Titers Interval 150.4 to 294.5
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	15.3 Titers Interval 9.5 to 24.6	6.3 Titers Interval 5.0 to 8.1	NA Titers Value below the cut-off value for the respective assay.	7.2 Titers Interval 5.0 to 10.3

SECONDARY outcome

Timeframe: At Days 0 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=19 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=9 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	7.2 Titers Interval 5.0 to 10.3	NA Titers Value below the cut-off value for the respective assay.	—	—
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 42	811.3 Titers Interval 628.4 to 1047.4	1279.9 Titers Interval 806.9 to 2030.4	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=9 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 182	347.9 Titers Interval 254.0 to 476.5	161.9 Titers Interval 133.7 to 196.1	154.0 Titers Interval 100.3 to 236.5	165.8 Titers Interval 131.9 to 208.5
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Flu A/CAL/7/09, Day 0	14.8 Titers Interval 9.1 to 24.1	6.4 Titers Interval 5.0 to 8.2	NA Titers Value below the cut-off value for the respective assay.	7.2 Titers Interval 5.0 to 10.3

SECONDARY outcome

Timeframe: At Day 21

Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=10 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroconverted Subjects for HI Antibodies	27 Subjects	29 Subjects	10 Subjects	19 Subjects

SECONDARY outcome

Timeframe: At Day 42

Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=19 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=9 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroconverted Subjects for HI Antibodies	19 Subjects	9 Subjects	—	—

SECONDARY outcome

Timeframe: At Day 182

Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=9 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroconverted Subjects for HI Antibodies	26 Subjects	27 Subjects	9 Subjects	18 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 21

A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=10 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 0	8 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 21	29 Subjects	29 Subjects	10 Subjects	19 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 42

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=19 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=9 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 0	1 Subjects	0 Subjects	—	—
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 42	19 Subjects	9 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was \> 70%.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=9 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 0	7 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Seroprotected Subjects for HI Antibodies Flu A/CAL/7/09, Day 182	29 Subjects	28 Subjects	9 Subjects	19 Subjects

SECONDARY outcome

Timeframe: At Day 21

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=10 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	22.1 Titers Interval 13.6 to 35.9	27.1 Titers Interval 20.4 to 36.1	23.5 Titers Interval 14.4 to 38.2	29.3 Titers Interval 19.9 to 42.9

SECONDARY outcome

Timeframe: At Day 42

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=19 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=9 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	112.8 Titers Interval 74.6 to 170.5	256.0 Titers Interval 161.4 to 406.1	—	—

SECONDARY outcome

Timeframe: At Day 182

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for SCF was \> 2.5.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup n=9 Participants Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup n=19 Participants Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease	23.5 Titers Interval 14.9 to 37.1	25.3 Titers Interval 18.4 to 34.7	30.8 Titers Interval 20.1 to 47.3	23.1 Titers Interval 14.9 to 35.8

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.

The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Flu A/Neth/602/09 H1N1, Day 0 (N=29;30)	14 Subjects	3 Subjects	—	—
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Flu A/Neth/602/09 H1N1, Day 21 (N=29;29)	28 Subjects	28 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Flu A/Neth/602/09 H1N1, Day 0	14 Subjects	3 Subjects	—	—
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Flu A/Neth/602/09 H1N1, Day 42	30 Subjects	28 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Flu A/Neth/602/09 H1N1, Day 0	13 Subjects	3 Subjects	—	—
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value Flu A/Neth/602/09 H1N1, Day 182	29 Subjects	28 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and 21

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09 H1N1, Day 0 (N=29;30)	11.3 Titers Interval 6.8 to 18.9	4.9 Titers Interval 3.7 to 6.5	—	—
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09 H1N1, Day 21 (N=29;29)	121.2 Titers Interval 68.4 to 214.9	53.8 Titers Interval 31.2 to 92.7	—	—

SECONDARY outcome

Timeframe: At Days 0 and 42

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09 H1N1, Day 0	11.3 Titers Interval 6.8 to 18.9	4.9 Titers Interval 3.7 to 6.6	—	—
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09 H1N1, Day 42	702.4 Titers Interval 433.5 to 1138.0	551.1 Titers Interval 417.0 to 728.5	—	—

SECONDARY outcome

Timeframe: At Days 0 and 182

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09 H1N1, Day 0	11.4 Titers Interval 6.7 to 19.4	4.9 Titers Interval 3.7 to 6.6	—	—
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease Flu A/Neth/602/09 H1N1, Day 182	213.3 Titers Interval 141.7 to 321.0	149.6 Titers Interval 104.7 to 213.6	—	—

SECONDARY outcome

Timeframe: At Day 21

VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=29 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1	17 Subjects	15 Subjects	—	—

SECONDARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=30 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1	30 Subjects	28 Subjects	—	—

SECONDARY outcome

Timeframe: At Day 182

Outcome measures

Outcome measures
Measure	GSK2340274A_F2 10Y-17Y Group n=29 Participants Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.	GSK2340274A_F1 6M-9Y Group n=28 Participants Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.	GSK2340274A_F1 6M-35M Subgroup Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.	GSK2340274A_F1 3Y-9Y Subgroup Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1	24 Subjects	27 Subjects	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on The Total Vaccinated Cohort which included all vaccinated subjects.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain \[child below (\<) 6 years\] = cried when limb was moved/spontaneously painful. Grade 3 pain \[child equal to or above (≥) 6 years\] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.