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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001169
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : May 2, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 30 30
Completed 28 29
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 30 participants 30 participants 60 participants
49.00  (27.66) 163.00  (32.41) 106.00  (64.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
16
  53.3%
18
  60.0%
34
  56.7%
Male
14
  46.7%
12
  40.0%
26
  43.3%
1.Primary Outcome
Title Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value
Hide Description

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.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: Subjects
28 30
2.Primary Outcome
Title Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description 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.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Geometric Mean (97.5% Confidence Interval)
Unit of Measure: Titers
939.3
(722.9 to 1220.6)
874.3
(717.4 to 1065.4)
3.Primary Outcome
Title Number of Seroconverted Subjects for HI Antibodies
Hide Description

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%.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: Subjects
28 30
4.Primary Outcome
Title Number of Seroprotected Subjects for HI Antibodies
Hide Description

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%.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: Subjects
28 30
5.Primary Outcome
Title Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description

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.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Geometric Mean (97.5% Confidence Interval)
Unit of Measure: Titers
146.8
(99.6 to 216.4)
57.1
(33.5 to 97.3)
6.Secondary Outcome
Title Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Hide Description 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.
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 29 30 10 19
Measure Type: Number
Unit of Measure: Subjects
Flu A/CAL/7/09, Day 0 5 18 0 5
Flu A/CAL/7/09, Day 21 29 30 10 19
7.Secondary Outcome
Title Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Hide Description

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.

Time Frame At Days 0 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 19
Measure Type: Number
Unit of Measure: Subjects
Flu A/CAL/7/09, Day 0 0 5
Flu A/CAL/7/09, Day 42 9 19
8.Secondary Outcome
Title Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Hide Description 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.
Time Frame At Days 0 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 28 29 9 19
Measure Type: Number
Unit of Measure: Subjects
Flu A/CAL/7/09, Day 0 5 17 0 5
Flu A/CAL/7/09, Day 182 28 29 9 19
9.Secondary Outcome
Title Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description 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.
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 29 30 10 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, Day 0
6.3
(5.0 to 8.1)
15.3
(9.5 to 24.6)
NA [1] 
(NA to NA)
7.2
(5.0 to 10.3)
Flu A/CAL/7/09, Day 21
172.0
(130.1 to 227.6)
339.0
(238.8 to 481.2)
117.3
(72.2 to 190.8)
210.4
(150.4 to 294.5)
[1]
Value below the cut-off value for the respective assay.
10.Secondary Outcome
Title Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description

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.

Time Frame At Days 0 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, Day 0
NA [1] 
(NA to NA)
7.2
(5.0 to 10.3)
Flu A/CAL/7/09, Day 42
1279.9
(806.9 to 2030.4)
811.3
(628.4 to 1047.4)
[1]
Value below the cut-off value for the respective assay.
11.Secondary Outcome
Title Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description 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.
Time Frame At Days 0 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 28 29 9 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, Day 0
6.4
(5.0 to 8.2)
14.8
(9.1 to 24.1)
NA [1] 
(NA to NA)
7.2
(5.0 to 10.3)
Flu A/CAL/7/09, Day 182
161.9
(133.7 to 196.1)
347.9
(254.0 to 476.5)
154.0
(100.3 to 236.5)
165.8
(131.9 to 208.5)
[1]
Value below the cut-off value for the respective assay.
12.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies
Hide Description

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%.

Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 29 30 10 19
Measure Type: Number
Unit of Measure: Subjects
29 27 10 19
13.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies
Hide Description

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.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 19
Measure Type: Number
Unit of Measure: Subjects
9 19
14.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies
Hide Description

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%.

Time Frame At Day 182
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Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 28 29 9 19
Measure Type: Number
Unit of Measure: Subjects
27 26 9 18
15.Secondary Outcome
Title Number of Seroprotected Subjects for HI Antibodies
Hide Description

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%.

Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 29 30 10 19
Measure Type: Number
Unit of Measure: Subjects
Flu A/CAL/7/09, Day 0 1 8 0 1
Flu A/CAL/7/09, Day 21 29 29 10 19
16.Secondary Outcome
Title Number of Seroprotected Subjects for HI Antibodies
Hide Description

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.

Time Frame At Days 0 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 19
Measure Type: Number
Unit of Measure: Subjects
Flu A/CAL/7/09, Day 0 0 1
Flu A/CAL/7/09, Day 42 9 19
17.Secondary Outcome
Title Number of Seroprotected Subjects for HI Antibodies
Hide Description

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%.

Time Frame At Days 0 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 28 29 9 19
Measure Type: Number
Unit of Measure: Subjects
Flu A/CAL/7/09, Day 0 1 7 0 1
Flu A/CAL/7/09, Day 182 28 29 9 19
18.Secondary Outcome
Title Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description

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.

Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 29 30 10 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
27.1
(20.4 to 36.1)
22.1
(13.6 to 35.9)
23.5
(14.4 to 38.2)
29.3
(19.9 to 42.9)
19.Secondary Outcome
Title SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description

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.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
256.0
(161.4 to 406.1)
112.8
(74.6 to 170.5)
20.Secondary Outcome
Title SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Hide Description

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.

Time Frame At Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group GSK2340274A_F1 6M-35M Subgroup GSK2340274A_F1 3Y-9Y Subgroup
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 28 29 9 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
25.3
(18.4 to 34.7)
23.5
(14.9 to 37.1)
30.8
(20.1 to 47.3)
23.1
(14.9 to 35.8)
21.Secondary Outcome
Title Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Hide Description 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.
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: Subjects
Flu A/Neth/602/09 H1N1, Day 0 (N=29;30) 3 14
Flu A/Neth/602/09 H1N1, Day 21 (N=29;29) 28 28
22.Secondary Outcome
Title Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Hide Description 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.
Time Frame At Days 0 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: Subjects
Flu A/Neth/602/09 H1N1, Day 0 3 14
Flu A/Neth/602/09 H1N1, Day 42 28 30
23.Secondary Outcome
Title Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Hide Description 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.
Time Frame At Days 0 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 29
Measure Type: Number
Unit of Measure: Subjects
Flu A/Neth/602/09 H1N1, Day 0 3 13
Flu A/Neth/602/09 H1N1, Day 182 28 29
24.Secondary Outcome
Title Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Hide Description 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.
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Neth/602/09 H1N1, Day 0 (N=29;30)
4.9
(3.7 to 6.5)
11.3
(6.8 to 18.9)
Flu A/Neth/602/09 H1N1, Day 21 (N=29;29)
53.8
(31.2 to 92.7)
121.2
(68.4 to 214.9)
25.Secondary Outcome
Title Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Hide Description 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.
Time Frame At Days 0 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Neth/602/09 H1N1, Day 0
4.9
(3.7 to 6.6)
11.3
(6.8 to 18.9)
Flu A/Neth/602/09 H1N1, Day 42
551.1
(417.0 to 728.5)
702.4
(433.5 to 1138.0)
26.Secondary Outcome
Title Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Hide Description 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.
Time Frame At Days 0 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Neth/602/09 H1N1, Day 0
4.9
(3.7 to 6.6)
11.4
(6.7 to 19.4)
Flu A/Neth/602/09 H1N1, Day 182
149.6
(104.7 to 213.6)
213.3
(141.7 to 321.0)
27.Secondary Outcome
Title Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: Subjects
15 17
28.Secondary Outcome
Title Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1
Hide Description 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.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
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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.
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 Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: Subjects
28 30
29.Secondary Outcome
Title Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1
Hide Description 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.
Time Frame At Day 182
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Hide Analysis Population Description
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.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 28 29
Measure Type: Number
Unit of Measure: Subjects
27 24
30.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description 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.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Hide Analysis Population Description
The analysis was performed on The Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-5Y Subgroup GSK2340274A_F1 6Y-9Y Subgroup GSK2340274A_F2 10Y-17Y Group
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Healthy male or female Japanese children, between and including 6 months to 5 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.
Healthy male or female Japanese children, between and including 6 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.
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 Number of Participants Analyzed 24 6 30
Measure Type: Number
Unit of Measure: Subjects
Any Pain, Dose 1 (N=24;6;30) 19 5 30
Grade 3 Pain, Dose 1 (N=24;6;30) 1 0 3
Any Redness, Dose 1 (N=24;6;30) 0 1 7
Grade 3 Redness, Dose 1 (N=24;6;30) 0 0 0
Any Swelling, Dose 1 (N=24;6;30) 5 2 14
Grade 3 Swelling, Dose 1 (N=24;6;30) 0 0 1
Any Pain, Dose 2 (N=23;6;30) 16 5 30
Grade 3 Pain, Dose 2 (N=23;6;30) 1 0 2
Any Redness, Dose 2 (N=23;6;30) 2 0 5
Grade 3 Redness, Dose 2 (N=23;6;30) 0 0 0
Any Swelling, Dose 2 (N=23;6;30) 4 2 15
Grade 3 Swelling, Dose 2 (N=23;6;30) 0 0 1
Any Pain, Across Doses (N=24;6;30) 19 6 30
Grade 3 Pain, Across Doses (N=24;6;30) 2 0 5
Any Redness, Across Doses (N=24;6;30) 2 1 10
Grade 3 Redness, Across Doses (N=24;6;30) 0 0 0
Any Swelling, Across Doses (N=24;6;30) 8 2 16
Grade 3 Swelling, Across Doses (N=24;6;30) 0 0 2
31.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-5Y Subgroup
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Healthy male or female Japanese children, between and including 6 months to 5 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.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Subjects
Any Drowsiness, Dose 1 (N=24) 5
Grade 3 Drowsiness, Dose 1 (N=24) 0
Related Drowsiness, Dose 1 (N=24) 5
Any Irritability, Dose 1 (N=24) 6
Grade 3 Irritability, Dose 1 (N=24) 1
Related Irritability, Dose 1 (N=24) 6
Any Loss of appetite, Dose 1 (N=24) 5
Grade 3 Loss of appetite, Dose 1 (N=24) 0
Related Loss of appetite, Dose 1 (N=24) 4
Any Fever, Dose 1 (N=24) 3
Grade 3 Fever, Dose 1 (N=24) 0
Related Fever, Dose 1 (N=24) 3
Any Drowsiness, Dose 2 (N=23) 7
Grade 3 Drowsiness, Dose 2 (N=23) 0
Related Drowsiness, Dose 2 (N=23) 7
Any Irritability, Dose 2 (N=23) 6
Grade 3 Irritability, Dose 2 (N=23) 0
Related Irritability, Dose 2 (N=23) 5
Any Loss of appetite, Dose 2 (N=23) 5
Grade 3 Loss of appetite, Dose 2 (N=23) 1
Related Loss of appetite, Dose 2 (N=23) 5
Any Fever, Dose 2 (N=23) 6
Grade 3 Fever, Dose 2 (N=23) 2
Related Fever, Dose 2 (N=23) 5
Any Drowsiness, Across doses (N=24) 8
Grade 3 Drowsiness, Across doses (N=24) 0
Related Drowsiness, Across doses (N=24) 8
Any Irritability, Across doses (N=24) 8
Grade 3 Irritability, Across doses (N=24) 1
Related Irritability, Across doses (N=24) 7
Any Loss of appetite, Across doses (N=24) 7
Grade 3 Loss of appetite, Across doses (N=24) 1
Related Loss of appetite, Across doses (N=24) 6
Any Fever, Across doses (N=24) 8
Grade 3 Fever, Across doses (N=24) 2
Related Fever, Across doses (N=24) 7
32.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location, muscle aches, shivering, sweating, and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C - ≤ 40.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6Y-9Y Subgroup GSK2340274A_F2 10Y-17Y Group
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Healthy male or female Japanese children, between and including 6 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.
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 Number of Participants Analyzed 6 30
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue, Dose 1 1 11
Grade 3 Fatigue, Dose 1 0 1
Related Fatigue, Dose 1 0 10
Any Gastrointestinal, Dose 1 1 3
Grade 3 Gastrointestinal, Dose 1 0 0
Related Gastrointestinal, Dose 1 0 3
Any Headache, Dose 1 2 12
Grade 3 Headache, Dose 1 0 0
Related Headache, Dose 1 0 11
Any Joint pain, Dose 1 0 5
Grade 3 Joint pain, Dose 1 0 0
Related Joint pain, Dose 1 0 4
Any Muscle aches, Dose 1 0 7
Grade 3 Muscle aches, Dose 1 0 0
Related Muscle aches, Dose 1 0 7
Any Shivering, Dose 1 1 7
Grade 3 Shivering, Dose 1 0 0
Related Shivering, Dose 1 1 6
Any Sweating, Dose 1 0 2
Grade 3 Sweating, Dose 1 0 1
Related Sweating, Dose 1 0 1
Any Fever, Dose 1 2 4
Grade 3 Fever, Dose 1 0 3
Related Fever, Dose 1 1 3
Any Fatigue, Dose 2 1 11
Grade 3 Fatigue, Dose 2 0 1
Related Fatigue, Dose 2 1 11
Any Gastrointestinal, Dose 2 1 3
Grade 3 Gastrointestinal, Dose 2 0 0
Related Gastrointestinal, Dose 2 1 3
Any Headache, Dose 2 1 17
Grade 3 Headache, Dose 2 0 2
Related Headache, Dose 2 1 16
Any Joint pain, Dose 2 0 7
Grade 3 Joint pain, Dose 2 0 0
Related Joint pain, Dose 2 0 6
Any Muscle aches, Dose 2 0 9
Grade 3 Muscle aches, Dose 2 0 0
Related Muscle aches, Dose 2 0 8
Any Shivering, Dose 2 0 8
Grade 3 Shivering, Dose 2 0 0
Related Shivering, Dose 2 0 8
Any Sweating, Dose 2 0 3
Grade 3 Sweating, Dose 2 0 0
Related Sweating, Dose 2 0 3
Any Fever, Dose 2 0 7
Grade 3 Fever, Dose 2 0 0
Related Fever, Dose 2 0 7
Any Fatigue, Across doses 2 14
Grade 3 Fatigue, Across doses 0 2
Related Fatigue, Across doses 1 14
Any Gastrointestinal, Across doses 2 4
Grade 3 Gastrointestinal, Across doses 0 0
Related Gastrointestinal, Across doses 1 4
Any Headache, Across doses 3 20
Grade 3 Headache, Across doses 0 2
Related Headache, Across doses 1 19
Any Joint pain, Across doses 0 9
Grade 3 Joint pain, Across doses 0 0
Related Joint pain, Across doses 0 8
Any Muscle aches, Across doses 0 11
Grade 3 Muscle aches, Across doses 0 0
Related Muscle aches, Across doses 0 10
Any Shivering, Across doses 1 11
Grade 3 Shivering, Across doses 0 0
Related Shivering, Across doses 1 11
Any Sweating, Across doses 0 5
Grade 3 Sweating, Across doses 0 1
Related Sweating, Across doses 0 4
Any Fever, Across doses 2 8
Grade 3 Fever, Across doses 0 3
Related Fever, Across doses 1 8
33.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Up to 84 days (Days 0-83) after the first vaccination
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Subjects
Any AE(s) 19 21
Grade 3 AE(s) 9 7
Related AE(s) 9 8
34.Secondary Outcome
Title Number of Subjects With Medically Attended Events (MAEs)
Hide Description MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time Frame During the entire study period (from Day 0 to Day 182)
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-5Y Subgroup GSK2340274A_F1 6Y-9Y Subgroup GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
Healthy male or female Japanese children, between and including 6 months to 5 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.
Healthy male or female Japanese children, between and including 6 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.
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 Number of Participants Analyzed 24 6 30
Measure Type: Number
Unit of Measure: Subjects
14 2 10
35.Secondary Outcome
Title Number of Subjects With Potential Immune-Mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame During the entire study period (from Day 0 to Day 182)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-5Y Subgroup GSK2340274A_F1 6Y-9Y Subgroup GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
Healthy male or female Japanese children, between and including 6 months to 5 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.
Healthy male or female Japanese children, between and including 6 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.
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 Number of Participants Analyzed 24 6 30
Measure Type: Number
Unit of Measure: Subjects
0 0 0
36.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (from Day 0 to Day 182)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Subjects
1 1
37.Secondary Outcome
Title Number of Subjects With Normal or Abnormal Biochemical Levels
Hide Description

Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN).

Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.

Time Frame At Days 0, 7 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-5Y Subgroup GSK2340274A_F1 6Y-9Y Subgroup GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
Healthy male or female Japanese children, between and including 6 months to 5 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.
Healthy male or female Japanese children, between and including 6 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.
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 Number of Participants Analyzed 23 6 30
Measure Type: Number
Unit of Measure: Subjects
ALAT Unknown, Day 0 (N=22;6;29) 0 0 0
ALAT Unknown, Day 7 (N=23;6;30) 0 0 0
ALAT Unknown, Day 42 (N=22;6;30) 0 0 0
ALAT Below, Day 0 (N=22;6;29) 0 0 0
ALAT Below, Day 7 (N=23;6;30) 0 0 0
ALAT Below, Day 42 (N=22;6;30) 0 0 0
ALAT Within, Day 0 (N=22;6;29) 22 6 28
ALAT Within, Day 7 (N=23;6;30) 23 6 28
ALAT Within, Day 42 (N=22;6;30) 22 6 30
ALAT Above, Day 0 (N=22;6;29) 0 0 1
ALAT Above, Day 7 (N=23;6;30) 0 0 2
ALAT Above, Day 42 (N=22;6;30) 0 0 0
Albumin Unknown, Day 0 (N=22;6;29) 0 0 0
Albumin Unknown, Day 7 (N=23;6;30) 0 0 0
Albumin Unknown, Day 42 (N=22;6;30) 0 0 0
Albumin Below, Day 0 (N=22;6;29) 0 0 0
Albumin Below, Day 7 (N=23;6;30) 0 0 0
Albumin Below, Day 42 (N=22;6;30) 2 0 1
Albumin Within, Day 0 (N=22;6;29) 21 6 27
Albumin Within, Day 7 (N=23;6;30) 22 6 29
Albumin Within, Day 42 (N=22;6;30) 19 6 28
Albumin Above, Day 0 (N=22;6;29) 1 0 2
Albumin Above, Day 7 (N=23;6;30) 1 0 1
Albumin Above, Day 42 (N=22;6;30) 1 0 1
AP Unknown, Day 0 (N=22;6;29) 0 0 0
AP Unknown, Day 7 (N=23;6;30) 0 0 0
AP Unknown, Day 42 (N=22;6;30) 1 0 0
AP Below, Day 0 (N=22;6;29) 0 0 0
AP Below, Day 7 (N=23;6;30) 0 0 0
AP Below, Day 42 (N=22;6;30) 0 0 0
AP Within, Day 0 (N=22;6;29) 0 0 8
AP Within, Day 7 (N=23;6;30) 0 0 9
AP Within, Day 42 (N=22;6;30) 0 0 9
AP Above, Day 0 (N=22;6;29) 22 6 21
AP Above, Day 7 (N=23;6;30) 23 6 21
AP Above, Day 42 (N=22;6;30) 21 6 21
ASAT Unknown, Day 0 (N=22;6;29) 0 0 0
ASAT Unknown, Day 7 (N=23;6;30) 0 0 0
ASAT Unknown, Day 42 (N=22;6;30) 1 0 0
ASAT Below, Day 0 (N=22;6;29) 0 0 1
ASAT Below, Day 7 (N=23;6;30) 0 0 0
ASAT Below, Day 42 (N=22;6;30) 0 0 0
ASAT Within, Day 0 (N=22;6;29) 21 6 27
ASAT Within, Day 7 (N=23;6;30) 21 6 30
ASAT Within, Day 42 (N=22;6;30) 20 6 30
ASAT Above, Day 0 (N=22;6;29) 1 0 1
ASAT Above, Day 7 (N=23;6;30) 2 0 0
ASAT Above, Day 42 (N=22;6;30) 1 0 0
Bilirubin Unknown, Day 0 (N=22;6;29) 0 0 0
Bilirubin Unknown, Day 7 (N=23;6;30) 0 0 0
Bilirubin Unknown, Day 42 (N=22;6;30) 0 0 0
Bilirubin Below, Day 0 (N=22;6;29) 0 0 0
Bilirubin Below, Day 7 (N=23;6;30) 0 0 0
Bilirubin Below, Day 42 (N=22;6;30) 0 0 0
Bilirubin Within, Day 0 (N=22;6;29) 22 6 29
Bilirubin Within, Day 7 (N=23;6;30) 23 6 30
Bilirubin Within, Day 42 (N=22;6;30) 22 6 29
Bilirubin Above, Day 0 (N=22;6;29) 0 0 0
Bilirubin Above, Day 7 (N=23;6;30) 0 0 0
Bilirubin Above, Day 42 (N=22;6;30) 0 0 1
Bilirubin Conj./Direct Unknown, Day 0 (N=22;6;29) 0 0 0
Bilirubin Conj./Direct Unknown, Day 7 (N=23;6;30) 0 0 0
Bilirubin Conj./Direct Unknown, Day 42 (N=22;6;30) 0 0 0
Bilirubin Conj./Direct Below, Day 0 (N=22;6;29) 0 0 0
Bilirubin Conj./Direct Below, Day 7 (N=23;6;30) 0 0 0
Bilirubin Conj./Direct Below, Day 42 (N=22;6;30) 0 0 0
Bilirubin Conj./Direct Within, Day 0 (N=22;6;29) 22 6 28
Bilirubin Conj./Direct Within, Day 7 (N=23;6;30) 23 6 30
Bilirubin Conj./Direct Within, Day 42 (N=22;6;30) 22 6 27
Bilirubin Conj./Direct Above, Day 0 (N=22;6;29) 0 0 1
Bilirubin Conj./Direct Above, Day 7 (N=23;6;30) 0 0 0
Bilirubin Conj./Direct Above, Day 42 (N=22;6;30) 0 0 3
Cholesterol Unknown, Day 0 (N=22;6;29) 0 0 0
Cholesterol Unknown, Day 7 (N=23;6;30) 0 0 0
Cholesterol Unknown, Day 42 (N=22;6;30) 0 0 0
Cholesterol Below, Day 0 (N=22;6;29) 7 2 9
Cholesterol Below, Day 7 (N=23;6;30) 8 2 12
Cholesterol Below, Day 42 (N=22;6;30) 8 2 10
Cholesterol Within, Day 0 (N=22;6;29) 13 4 20
Cholesterol Within, Day 7 (N=23;6;30) 14 4 18
Cholesterol Within, Day 42 (N=22;6;30) 14 4 19
Cholesterol Above, Day 0 (N=22;6;29) 2 0 0
Cholesterol Above, Day 7 (N=23;6;30) 1 0 0
Cholesterol Above, Day 42 (N=22;6;30) 0 0 1
Chloride Unknown, Day 0 (N=22;6;29) 0 0 0
Chloride Unknown, Day 7 (N=23;6;30) 0 0 0
Chloride Unknown, Day 42 (N=22;6;30) 0 0 0
Chloride Below, Day 0 (N=22;6;29) 0 0 0
Chloride Below, Day 7 (N=23;6;30) 0 0 0
Chloride Below, Day 42 (N=22;6;30) 0 0 0
Chloride Within, Day 0 (N=22;6;29) 22 6 29
Chloride Within, Day 7 (N=23;6;30) 23 6 29
Chloride Within, Day 42 (N=22;6;30) 22 6 29
Chloride Above, Day 0 (N=22;6;29) 0 0 0
Chloride Above, Day 7 (N=23;6;30) 0 0 1
Chloride Above, Day 42 (N=22;6;30) 0 0 1
Creatinine Unknown, Day 0 (N=22;6;29) 0 0 0
Creatinine Unknown, Day 7 (N=23;6;30) 0 0 0
Creatinine Unknown, Day 42 (N=22;6;30) 0 0 0
Creatinine Below, Day 0 (N=22;6;29) 22 6 11
Creatinine Below, Day 7 (N=23;6;30) 23 6 8
Creatinine Below, Day 42 (N=22;6;30) 22 6 12
Creatinine Within, Day 0 (N=22;6;29) 0 0 18
Creatinine Within, Day 7 (N=23;6;30) 0 0 22
Creatinine Within, Day 42 (N=22;6;30) 0 0 18
Creatinine Above, Day 0 (N=22;6;29) 0 0 0
Creatinine Above, Day 7 (N=23;6;30) 0 0 0
Creatinine Above, Day 42 (N=22;6;30) 0 0 0
CK Unknown, Day 0 (N=22;6;29) 0 0 0
CK Unknown, Day 7 (N=23;6;30) 0 0 0
CK Unknown, Day 42 (N=22;6;30) 0 0 0
CK Below, Day 0 (N=22;6;29) 0 0 0
CK Below, Day 7 (N=23;6;30) 0 0 0
CK Below, Day 42 (N=22;6;30) 0 0 0
CK Within, Day 0 (N=22;6;29) 17 6 28
CK Within, Day 7 (N=23;6;30) 19 6 28
CK Within, Day 42 (N=22;6;30) 20 5 27
CK Above, Day 0 (N=22;6;29) 5 0 1
CK Above, Day 7 (N=23;6;30) 4 0 2
CK Above, Day 42 (N=22;6;30) 2 1 3
GGT Unknown, Day 0 (N=22;6;29) 0 0 0
GGT Unknown, Day 7 (N=23;6;30) 0 0 0
GGT Unknown, Day 42 (N=22;6;30) 0 0 0
GGT Below, Day 0 (N=22;6;29) 0 0 0
GGT Below, Day 7 (N=23;6;30) 0 0 0
GGT Below, Day 42 (N=22;6;30) 0 0 0
GGT Within, Day 0 (N=22;6;29) 22 6 29
GGT Within, Day 7 (N=23;6;30) 23 6 29
GGT Within, Day 42 (N=22;6;30) 22 6 29
GGT Above, Day 0 (N=22;6;29) 0 0 0
GGT Above, Day 7 (N=23;6;30) 0 0 1
GGT Above, Day 42 (N=22;6;30) 0 0 1
Potassium Unknown, Day 0 (N=22;6;29) 0 0 0
Potassium Unknown, Day 7 (N=23;6;30) 0 0 0
Potassium Unknown, Day 42 (N=22;6;30) 1 0 0
Potassium Below, Day 0 (N=22;6;29) 0 0 0
Potassium Below, Day 7 (N=23;6;30) 0 0 0
Potassium Below, Day 42 (N=22;6;30) 0 0 0
Potassium Within, Day 0 (N=22;6;29) 21 6 29
Potassium Within, Day 7 (N=23;6;30) 23 6 30
Potassium Within, Day 42 (N=22;6;30) 20 6 30
Potassium Above, Day 0 (N=22;6;29) 1 0 0
Potassium Above, Day 7 (N=23;6;30) 0 0 0
Potassium Above, Day 42 (N=22;6;30) 1 0 0
LDH Unknown, Day 0 (N=22;6;29) 0 0 0
LDH Unknown, Day 7 (N=23;6;30) 0 0 0
LDH Unknown, Day 42 (N=22;6;30) 1 0 0
LDH Below, Day 0 (N=22;6;29) 0 0 0
LDH Below, Day 7 (N=23;6;30) 0 0 0
LDH Below, Day 42 (N=22;6;30) 0 0 0
LDH Within, Day 0 (N=22;6;29) 4 2 26
LDH Within, Day 7 (N=23;6;30) 2 2 29
LDH Within, Day 42 (N=22;6;30) 5 2 27
LDH Above, Day 0 (N=22;6;29) 18 4 3
LDH Above, Day 7 (N=23;6;30) 21 4 1
LDH Above, Day 42 (N=22;6;30) 16 4 3
Sodium Unknown, Day 0 (N=22;6;29) 0 0 0
Sodium Unknown, Day 7 (N=23;6;30) 0 0 0
Sodium Unknown, Day 42 (N=22;6;30) 0 0 0
Sodium Below, Day 0 (N=22;6;29) 0 0 0
Sodium Below, Day 7 (N=23;6;30) 0 0 0
Sodium Below, Day 42 (N=22;6;30) 0 0 0
Sodium Within, Day 0 (N=22;6;29) 22 6 29
Sodium Within, Day 7 (N=23;6;30) 23 6 30
Sodium Within, Day 42 (N=22;6;30) 22 6 30
Sodium Above, Day 0 (N=22;6;29) 0 0 0
Sodium Above, Day 7 (N=23;6;30) 0 0 0
Sodium Above, Day 42 (N=22;6;30) 0 0 0
Protein Unknown, Day 0 (N=22;6;29) 0 0 0
Protein Unknown, Day 7 (N=23;6;30) 0 0 0
Protein Unknown, Day 42 (N=22;6;30) 1 0 0
Protein Below, Day 0 (N=22;6;29) 2 0 4
Protein Below, Day 7 (N=23;6;30) 3 1 1
Protein Below, Day 42 (N=22;6;30) 2 0 3
Protein Within, Day 0 (N=22;6;29) 20 6 25
Protein Within, Day 7 (N=23;6;30) 20 5 29
Protein Within, Day 42 (N=22;6;30) 19 6 27
Protein Above, Day 0 (N=22;6;29) 0 0 0
Protein Above, Day 7 (N=23;6;30) 0 0 0
Protein Above, Day 42 (N=22;6;30) 0 0 0
Urate/Uric acid Unknown, Day 0 (N=22;6;29) 0 0 0
Urate/Uric acid Unknown, Day 7 (N=23;6;30) 0 0 0
Urate/Uric acid Unknown, Day 42 (N=22;6;30) 0 0 0
Urate/Uric acid Below, Day 0 (N=22;6;29) 9 2 0
Urate/Uric acid Below, Day 7 (N=23;6;30) 9 2 2
Urate/Uric acid Below, Day 42 (N=22;6;30) 9 2 2
Urate/Uric acid Within, Day 0 (N=22;6;29) 13 4 27
Urate/Uric acid Within, Day 7 (N=23;6;30) 14 4 26
Urate/Uric acid Within, Day 42 (N=22;6;30) 13 4 26
Urate/Uric acid Above, Day 0 (N=22;6;29) 0 0 2
Urate/Uric acid Above, Day 7 (N=23;6;30) 0 0 2
Urate/Uric acid Above, Day 42 (N=22;6;30) 0 0 2
BUN Unknown, Day 0 (N=22;6;29) 0 0 0
BUN Unknown, Day 7 (N=23;6;30) 0 0 0
BUN Unknown, Day 42 (N=22;6;30) 0 0 0
BUN Below, Day 0 (N=22;6;29) 0 0 0
BUN Below, Day 7 (N=23;6;30) 1 0 0
BUN Below, Day 42 (N=22;6;30) 0 0 1
BUN Within, Day 0 (N=22;6;29) 22 6 29
BUN Within, Day 7 (N=23;6;30) 21 6 30
BUN Within, Day 42 (N=22;6;30) 22 6 28
BUN Above, Day 0 (N=22;6;29) 0 0 0
BUN Above, Day 7 (N=23;6;30) 1 0 0
BUN Above, Day 42 (N=22;6;30) 0 0 1
38.Secondary Outcome
Title Number of Subjects With Normal or Abnormal Values of Haematological Parameters
Hide Description

Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC).

Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.

Time Frame At Days 0, 7 and 42
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK2340274A_F1 6M-5Y Subgroup GSK2340274A_F1 6Y-9Y Subgroup GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description:
Healthy male or female Japanese children, between and including 6 months to 5 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.
Healthy male or female Japanese children, between and including 6 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.
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 Number of Participants Analyzed 23 6 30
Measure Type: Number
Unit of Measure: Subjects
BAS Unknown, Day 0 (N=22;6;29) 0 0 1
BAS Unknown, Day 7 (N=23;6;30) 0 0 0
BAS Unknown, Day 42 (N=22;6;30) 0 0 0
BAS Below, Day 0 (N=22;6;29) 0 0 0
BAS Below, Day 7 (N=23;6;30) 0 0 0
BAS Below, Day 42 (N=22;6;30) 0 0 0
BAS Within, Day 0 (N=22;6;29) 22 6 28
BAS Within, Day 7 (N=23;6;30) 23 6 30
BAS Within, Day 42 (N=22;6;30) 22 6 30
BAS Above, Day 0 (N=22;6;29) 0 0 0
BAS Above, Day 7 (N=23;6;30) 0 0 0
BAS Above, Day 42 (N=22;6;30) 0 0 0
EOS Unknown, Day 0 (N=22;6;29) 0 0 1
EOS Unknown, Day 7 (N=23;6;30) 0 0 0
EOS Unknown, Day 42 (N=22;6;30) 0 0 0
EOS Below, Day 0 (N=22;6;29) 0 0 0
EOS Below, Day 7 (N=23;6;30) 0 0 0
EOS Below, Day 42 (N=22;6;30) 0 0 0
EOS Within, Day 0 (N=22;6;29) 18 6 23
EOS Within, Day 7 (N=23;6;30) 21 6 25
EOS Within, Day 42 (N=22;6;30) 21 6 27
EOS Above, Day 0 (N=22;6;29) 4 0 5
EOS Above, Day 7 (N=23;6;30) 2 0 5
EOS Above, Day 42 (N=22;6;30) 1 0 3
HEM Unknown, Day 0 (N=22;6;29) 0 0 1
HEM Unknown, Day 7 (N=23;6;30) 0 0 0
HEM Unknown, Day 42 (N=22;6;30) 0 0 0
HEM Below, Day 0 (N=22;6;29) 7 3 1
HEM Below, Day 7 (N=23;6;30) 7 3 3
HEM Below, Day 42 (N=22;6;30) 9 3 4
HEM Within, Day 0 (N=22;6;29) 15 3 25
HEM Within, Day 7 (N=23;6;30) 16 3 26
HEM Within, Day 42 (N=22;6;30) 13 3 26
HEM Above, Day 0 (N=22;6;29) 0 0 2
HEM Above, Day 7 (N=23;6;30) 0 0 1
HEM Above, Day 42 (N=22;6;30) 0 0 0
Hgb Unknown, Day 0 (N=22;6;29) 0 0 1
Hgb Unknown, Day 7 (N=23;6;30) 0 0 0
Hgb Unknown, Day 42 (N=22;6;30) 0 0 0
Hgb Below, Day 0 (N=22;6;29) 10 3 8
Hgb Below, Day 7 (N=23;6;30) 10 4 8
Hgb Below, Day 42 (N=22;6;30) 12 3 6
Hgb Within, Day 0 (N=22;6;29) 12 3 20
Hgb Within, Day 7 (N=23;6;30) 13 2 22
Hgb Within, Day 42 (N=22;6;30) 10 3 24
Hgb Above, Day 0 (N=22;6;29) 0 0 0
Hgb Above, Day 7 (N=23;6;30) 0 0 0
Hgb Above, Day 42 (N=22;6;30) 0 0 0
LYM Unknown, Day 0 (N=22;6;29) 0 0 1
LYM Unknown, Day 7 (N=23;6;30) 0 0 0
LYM Unknown, Day 42 (N=22;6;30) 0 0 0
LYM Below, Day 0 (N=22;6;29) 0 0 0
LYM Below, Day 7 (N=23;6;30) 0 0 0
LYM Below, Day 42 (N=22;6;30) 0 0 0
LYM Within, Day 0 (N=22;6;29) 18 6 28
LYM Within, Day 7 (N=23;6;30) 17 6 29
LYM Within, Day 42 (N=22;6;30) 18 6 30
LYM Above, Day 0 (N=22;6;29) 4 0 0
LYM Above, Day 7 (N=23;6;30) 6 0 1
LYM Above, Day 42 (N=22;6;30) 4 0 0
MON Unknown, Day 0 (N=22;6;29) 0 0 1
MON Unknown, Day 7 (N=23;6;30) 0 0 0
MON Unknown, Day 42 (N=22;6;30) 0 0 0
MON Below, Day 0 (N=22;6;29) 0 0 0
MON Below, Day 7 (N=23;6;30) 0 0 0
MON Below, Day 42 (N=22;6;30) 0 0 0
MON Within, Day 0 (N=22;6;29) 21 6 27
MON Within, Day 7 (N=23;6;30) 21 6 29
MON Within, Day 42 (N=22;6;30) 22 6 28
MON Above, Day 0 (N=22;6;29) 1 0 1
MON Above, Day 7 (N=23;6;30) 2 0 1
MON Above, Day 42 (N=22;6;30) 0 0 2
NEU Unknown, Day 0 (N=22;6;29) 0 0 1
NEU Unknown, Day 7 (N=23;6;30) 0 0 0
NEU Unknown, Day 42 (N=22;6;30) 0 0 0
NEU Below, Day 0 (N=22;6;29) 8 0 1
NEU Below, Day 7 (N=23;6;30) 12 1 1
NEU Below, Day 42 (N=22;6;30) 7 0 1
NEU Within, Day 0 (N=22;6;29) 14 6 27
NEU Within, Day 7 (N=23;6;30) 11 5 29
NEU Within, Day 42 (N=22;6;30) 15 6 29
NEU Above, Day 0 (N=22;6;29) 0 0 0
NEU Above, Day 7 (N=23;6;30) 0 0 0
NEU Above, Day 42 (N=22;6;30) 0 0 0
PLA Unknown, Day 0 (N=22;6;29) 0 0 1
PLA Unknown, Day 7 (N=23;6;30) 0 0 0
PLA Unknown, Day 42 (N=22;6;30) 0 0 0
PLA Below, Day 0 (N=22;6;29) 1 0 0
PLA Below, Day 7 (N=23;6;30) 0 0 0
PLA Below, Day 42 (N=22;6;30) 1 0 0
PLA Within, Day 0 (N=22;6;29) 16 6 27
PLA Within, Day 7 (N=23;6;30) 14 5 29
PLA Within, Day 42 (N=22;6;30) 13 5 29
PLA Above, Day 0 (N=22;6;29) 5 0 1
PLA Above, Day 7 (N=23;6;30) 9 1 1
PLA Above, Day 42 (N=22;6;30) 8 1 1
RBC Unknown, Day 0 (N=22;6;29) 0 0 1
RBC Unknown, Day 7 (N=23;6;30) 0 0 0
RBC Unknown, Day 42 (N=22;6;30) 0 0 0
RBC Below, Day 0 (N=22;6;29) 0 0 0
RBC Below, Day 7 (N=23;6;30) 0 0 0
RBC Below, Day 42 (N=22;6;30) 0 1 0
RBC Within, Day 0 (N=22;6;29) 21 6 26
RBC Within, Day 7 (N=23;6;30) 22 6 28
RBC Within, Day 42 (N=22;6;30) 20 5 29
RBC Above, Day 0 (N=22;6;29) 1 0 2
RBC Above, Day 7 (N=23;6;30) 1 0 2
RBC Above, Day 42 (N=22;6;30) 2 0 1
WBC Unknown, Day 0 (N=22;6;29) 0 0 1
WBC Unknown, Day 7 (N=23;6;30) 0 0 0
WBC Unknown, Day 42 (N=22;6;30) 0 0 0
WBC Below, Day 0 (N=22;6;29) 0 0 0
WBC Below, Day 7 (N=23;6;30) 0 0 0
WBC Below, Day 42 (N=22;6;30) 0 0 0
WBC Within, Day 0 (N=22;6;29) 14 6 28
WBC Within, Day 7 (N=23;6;30) 10 5 30
WBC Within, Day 42 (N=22;6;30) 12 4 29
WBC Above, Day 0 (N=22;6;29) 8 0 0
WBC Above, Day 7 (N=23;6;30) 13 1 0
WBC Above, Day 42 (N=22;6;30) 10 2 1
Time Frame Solicited local and general symptoms: during the 7-day (Day 0-6) post-vaccination period; Unsolicited AEs: up to 84 days (Days 0-83) after the first vaccination; SAEs: during the entire study period (from Day 0 up to Day 182).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   1/30 (3.33%) 
Injury, poisoning and procedural complications     
Foot fracture  1  0/30 (0.00%)  1/30 (3.33%) 
Nervous system disorders     
Febrile convulsion  1  1/30 (3.33%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK2340274A_F1 6M-9Y Group GSK2340274A_F2 10Y-17Y Group
Affected / at Risk (%) Affected / at Risk (%)
Total   30/30 (100.00%)   30/30 (100.00%) 
Eye disorders     
Eye discharge  1  2/30 (6.67%)  0/30 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  3/30 (10.00%)  0/30 (0.00%) 
Vomiting  1  3/30 (10.00%)  1/30 (3.33%) 
General disorders     
Pain  1  25/30 (83.33%)  30/30 (100.00%) 
Redness  1  3/30 (10.00%)  10/30 (33.33%) 
Swelling  1  10/30 (33.33%)  16/30 (53.33%) 
Drowsiness (6m-5y)  1  8/24 (33.33%)  0/0 
Irritability (6m-5y)  1  8/24 (33.33%)  0/0 
Loss of appetite (6m-5y)  1  7/24 (29.17%)  0/0 
Fatigue (6y-9y + 10y-17y)  1  2/6 (33.33%)  14/30 (46.67%) 
Gastrointestinal (6y-9y + 10y-17y)  1  2/6 (33.33%)  4/30 (13.33%) 
Headache (6y-9y + 10y-17y)  1  3/6 (50.00%)  20/30 (66.67%) 
Joint pain (6y-9y + 10y-17y)  1  0/6 (0.00%)  9/30 (30.00%) 
Muscle aches (6y-9y + 10y-17y)  1  0/6 (0.00%)  11/30 (36.67%) 
Shivering (6y-9y + 10y-17y)  1  1/6 (16.67%)  11/30 (36.67%) 
Sweating (6y-9y + 10y-17y)  1  0/6 (0.00%)  5/30 (16.67%) 
Temperature (Axillary)  1  10/30 (33.33%)  8/30 (26.67%) 
Pyrexia  1  6/30 (20.00%)  2/30 (6.67%) 
Axillary pain  1  0/30 (0.00%)  2/30 (6.67%) 
Infections and infestations     
Upper respiratory tract infection  1  6/30 (20.00%)  1/30 (3.33%) 
Gastroenteritis  1  3/30 (10.00%)  0/30 (0.00%) 
Nasopharyngitis  1  3/30 (10.00%)  1/30 (3.33%) 
Bronchitis  1  2/30 (6.67%)  1/30 (3.33%) 
Influenza  1  1/30 (3.33%)  2/30 (6.67%) 
Pharyngitis  1  0/30 (0.00%)  2/30 (6.67%) 
Nervous system disorders     
Headache  1  0/30 (0.00%)  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/30 (23.33%)  2/30 (6.67%) 
Rhinorrhoea  1  7/30 (23.33%)  1/30 (3.33%) 
Rhinitis allergic  1  1/30 (3.33%)  2/30 (6.67%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/30 (0.00%)  2/30 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01001169    
Other Study ID Numbers: 113847
First Submitted: October 22, 2009
First Posted: October 23, 2009
Results First Submitted: March 14, 2017
Results First Posted: May 2, 2017
Last Update Posted: August 17, 2018