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Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children

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ClinicalTrials.gov Identifier: NCT00972517
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : September 10, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: GSK investigational vaccine GSK2340272A
Enrollment 245
Recruitment Details One subject was enrolled but not vaccinated and therefore, was not included in the number of subjects under "STARTED"
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Period Title: Overall Study
Started 31 31 60 30 34 58
Completed 31 30 60 27 33 58
Not Completed 0 1 0 3 1 0
Reason Not Completed
Adverse Event             0             0             0             1             0             0
Withdrawal by Subject             0             1             0             2             1             0
Arm/Group Title Group A
Hide Arm/Group Description Subjects receiving alternative dose of GSK23440272A vaccine
Overall Number of Baseline Participants 244
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants
9.2  (4.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants
Female
116
  47.5%
Male
128
  52.5%
1.Primary Outcome
Title Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs).
Time Frame At Day 0, Day 21 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all subjects for whom 2 doses were administrated and assay results were available for the blood samples taken before the first vaccination (Day 0), before the second vaccination (Day 21) and after the second vaccine dose (Day 42). No blood samples were planned at Day 0 and Day 21 for Flu BS2 Groups.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 28 30 54 25 30 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1, Day 0 Number Analyzed 28 participants 30 participants 54 participants 0 participants 0 participants 0 participants
5.7
(4.5 to 7.2)
5.2
(4.8 to 5.8)
9.9
(7 to 14.1)
H1N1, Day 21 Number Analyzed 28 participants 30 participants 54 participants 0 participants 0 participants 0 participants
192.6
(145.6 to 254.8)
190.3
(147 to 246.3)
479.3
(361.8 to 634.9)
H1N1, Day 42 Number Analyzed 28 participants 30 participants 54 participants 25 participants 30 participants 57 participants
1361.7
(1107 to 1674.9)
970.1
(765.8 to 1228.8)
1069.4
(892.6 to 1281.3)
1161.7
(905.2 to 1490.9)
915.7
(759.1 to 1104.6)
979.6
(845.3 to 1135.2)
2.Primary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Hide Description A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion at Day 42 could not be computed for those groups.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Overall Number of Participants Analyzed 28 30 54
Measure Type: Count of Participants
Unit of Measure: Participants
28
 100.0%
30
 100.0%
53
  98.1%
3.Primary Outcome
Title Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity included all evaluable subjects for whom 2 doses were administrated and assay results were available for antibodies against H1N1 antigen for the blood sample taken after the second vaccine dose (Day 42).
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 28 30 54 25 30 57
Measure Type: Count of Participants
Unit of Measure: Participants
28
 100.0%
30
 100.0%
54
 100.0%
25
 100.0%
30
 100.0%
57
 100.0%
4.Primary Outcome
Title HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
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 CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, GMFR at Day 42 could not be computed for those groups.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Overall Number of Participants Analyzed 28 30 54
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
237.68
(175.28 to 322.29)
185.25
(142.09 to 241.52)
107.74
(76.64 to 151.45)
5.Secondary Outcome
Title Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Hide Description Antibody titers were expressed as geometric mean titers (GMTs)
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 6 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for antibodies against the study vaccine antigen component at Month 6.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 27 28 53 23 27 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
140.8
(118.2 to 167.6)
154.2
(126.5 to 187.9)
254.6
(199 to 325.7)
129.4
(94.6 to 176.9)
148.2
(119 to 184.4)
243.6
(185.9 to 319.3)
6.Secondary Outcome
Title Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Hide Description Antibody titers were expressed as geometric mean titers (GMTs)
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, GMTs could not be computed for those groups.
Arm/Group Title Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 20 26 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
48.5
(35.7 to 65.7)
60.5
(49.2 to 74.3)
132.8
(94.9 to 185.8)
7.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Hide Description A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available at pre-vaccination time points (Day 0 and Day 21) and post-vaccination time point (Month 6). No pre-vaccination blood samples were taken from Flu BS2 Groups and hence seroconversion could not be assessed for these groups.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Overall Number of Participants Analyzed 27 28 53
Measure Type: Count of Participants
Unit of Measure: Participants
27
 100.0%
28
 100.0%
50
  94.3%
8.Secondary Outcome
Title Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 27 28 53 23 27 47
Measure Type: Count of Participants
Unit of Measure: Participants
27
 100.0%
28
 100.0%
53
 100.0%
20
  87.0%
27
 100.0%
47
 100.0%
9.Secondary Outcome
Title Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Hide Description A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, no data were computed for these groups.
Arm/Group Title Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 20 26 41
Measure Type: Count of Participants
Unit of Measure: Participants
17
  85.0%
22
  84.6%
37
  90.2%
10.Secondary Outcome
Title HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
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 CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 6 including all subjects for whom assay results were available for antibodies against the study vaccine antigen component pre-vaccination (Day 0 and Day 21) and at Month 6. As no pre-vaccination blood samples were planned for the Flu BS2 Groups, GMFR at Month 6 could not be computed for those groups.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Overall Number of Participants Analyzed 27 28 53
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
27.44
(22.42 to 33.57)
29.35
(23.53 to 36.61)
25.32
(18.6 to 34.47)
11.Secondary Outcome
Title Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs).
Time Frame At Day 0, Day 21, Day 42 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at the considered time points. No blood samples were taken at Day 0 and Day 21 and hence no GMTs computed for the Flu BS2 Groups. This analysis was conducted on a randomly selected subset of one third of the subjects.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 16 15 14 12 13 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1, Day 0 Number Analyzed 16 participants 15 participants 14 participants 0 participants 0 participants 0 participants
4.9
(3.9 to 6.1)
7.1
(3.9 to 12.7)
8
(3 to 21.3)
H1N1, Day 21 Number Analyzed 16 participants 15 participants 14 participants 0 participants 0 participants 0 participants
27.7
(13 to 58.8)
65.9
(24.6 to 176.4)
109.4
(34.5 to 346.7)
H1N1, Day 42 Number Analyzed 16 participants 15 participants 14 participants 12 participants 13 participants 15 participants
433.2
(295.2 to 635.6)
473.7
(301.5 to 744.1)
438.4
(191.3 to 1004.8)
533.4
(298.4 to 953.7)
260.1
(141.9 to 476.6)
199.5
(112.7 to 353.2)
H1N1, Month 6 Number Analyzed 16 participants 15 participants 14 participants 12 participants 13 participants 15 participants
158.9
(110.4 to 228.8)
203.3
(133.7 to 309.3)
232.1
(81.8 to 658.4)
156.6
(89.8 to 273.3)
166
(88.7 to 310.6)
150.9
(62.7 to 363.1)
12.Secondary Outcome
Title Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs).
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at Month 12. No blood samples were planned at Month 12 the Flu BS1 Groups and hence no GMTs computed for these Groups. This analysis was conducted on a randomly selected subset of one third of the subjects.
Arm/Group Title Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 11 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
152.3
(88.8 to 261)
129.9
(71.2 to 236.8)
138.3
(71.6 to 267.2)
13.Secondary Outcome
Title Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Hide Description A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Time Frame At Day 21 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for immunogenicity including subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was conducted on a randomly selected subset of one third of the subjects.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Overall Number of Participants Analyzed 16 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1, Day 21
8
  50.0%
10
  66.7%
9
  64.3%
H1N1, Day 42
15
  93.8%
15
 100.0%
14
 100.0%
14.Secondary Outcome
Title Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Hide Description A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP cohort for antibody persistence at Month 6 including subjects with assay results available for Day 0, Day 21 and Month 6. As no pre-vaccination (Day 0/21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was done on a randomly selected subset of a third of the subjects.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Overall Number of Participants Analyzed 16 15 13
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
14
  93.3%
12
  92.3%
15.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet.
Arm/Group Title Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
Hide Arm/Group Description:
Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups
Overall Number of Participants Analyzed 60 65 118
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
40
  66.7%
49
  75.4%
96
  81.4%
Grade 3 Pain
4
   6.7%
9
  13.8%
11
   9.3%
Any Redness
28
  46.7%
28
  43.1%
46
  39.0%
Grade 3 Redness
4
   6.7%
2
   3.1%
4
   3.4%
Any Swelling
22
  36.7%
22
  33.8%
46
  39.0%
Grade 3 Swelling
2
   3.3%
3
   4.6%
10
   8.5%
16.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet.
Arm/Group Title Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
Hide Arm/Group Description:
Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups
Overall Number of Participants Analyzed 60 65 118
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
0
   0.0%
14
  21.5%
25
  21.2%
Grade 3 Arthralgia
0
   0.0%
1
   1.5%
3
   2.5%
Related Arthralgia
0
   0.0%
14
  21.5%
23
  19.5%
Any Diarrhoea
9
  15.0%
0
   0.0%
0
   0.0%
Grade 3 Diarrhoea
2
   3.3%
0
   0.0%
0
   0.0%
Related Diarrhoea
5
   8.3%
0
   0.0%
0
   0.0%
Any Drowsiness
20
  33.3%
0
   0.0%
0
   0.0%
Grade 3 Drowsiness
3
   5.0%
0
   0.0%
0
   0.0%
Related Drowsiness
18
  30.0%
0
   0.0%
0
   0.0%
Any Fatigue
0
   0.0%
24
  36.9%
53
  44.9%
Grade 3 Fatigue
0
   0.0%
4
   6.2%
6
   5.1%
Related Fatigue
0
   0.0%
23
  35.4%
50
  42.4%
Any Gastro-intestinal symptoms
0
   0.0%
13
  20.0%
30
  25.4%
Grade 3 Gastro-intestinal symptoms
0
   0.0%
1
   1.5%
5
   4.2%
Related Gastro-intestinal symptoms
0
   0.0%
10
  15.4%
23
  19.5%
Any Headache
0
   0.0%
19
  29.2%
61
  51.7%
Grade 3 Headache
0
   0.0%
4
   6.2%
10
   8.5%
Related Headache
0
   0.0%
19
  29.2%
56
  47.5%
Any Irritability
18
  30.0%
0
   0.0%
0
   0.0%
Grade 3 Irritability
1
   1.7%
0
   0.0%
0
   0.0%
Related Irritability
18
  30.0%
0
   0.0%
0
   0.0%
Any Loss of appetite
18
  30.0%
0
   0.0%
0
   0.0%
Grade 3 Loss of appetite
1
   1.7%
0
   0.0%
0
   0.0%
Related Loss of appetite
17
  28.3%
0
   0.0%
0
   0.0%
Any Myalgia
0
   0.0%
13
  20.0%
45
  38.1%
Grade 3 Myalgia
0
   0.0%
1
   1.5%
3
   2.5%
Related Myalgia
0
   0.0%
13
  20.0%
43
  36.4%
Any Shivering
10
  16.7%
10
  15.4%
35
  29.7%
Grade 3 Shivering
0
   0.0%
0
   0.0%
3
   2.5%
Related Shivering
9
  15.0%
9
  13.8%
33
  28.0%
Any Sweating
9
  15.0%
10
  15.4%
18
  15.3%
Grade 3 Sweating
0
   0.0%
0
   0.0%
1
   0.8%
Related Sweating
8
  13.3%
9
  13.8%
15
  12.7%
Any Fever (≥37.5°C)
27
  45.0%
13
  20.0%
30
  25.4%
Grade 3 Fever (>39°C)
4
   6.7%
3
   4.6%
4
   3.4%
Related Fever
23
  38.3%
11
  16.9%
23
  19.5%
17.Secondary Outcome
Title Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
Hide Description MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
Time Frame During the entire study period (Day 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 31 31 60 30 34 58
Measure Type: Count of Participants
Unit of Measure: Participants
22
  71.0%
19
  61.3%
36
  60.0%
24
  80.0%
16
  47.1%
34
  58.6%
18.Secondary Outcome
Title Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Time Frame During the entire study period (Day 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
Hide Arm/Group Description:
Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups
Overall Number of Participants Analyzed 61 65 118
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Flu pooled_3-5 Years Group Flu pooled_6-9 Years Group Flu pooled_10-17 Years Group
Hide Arm/Group Description:
Pooled data of subjects aged 3 to 5 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 6 to 9 years from the Flu BS1 and Flu BS2 Groups
Pooled data of subjects aged 10 to 17 years from the Flu BS1 and Flu BS2 Groups
Overall Number of Participants Analyzed 61 65 118
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
42
  68.9%
25
  38.5%
53
  44.9%
Grade 3 AE(s)
3
   4.9%
1
   1.5%
5
   4.2%
Related AE(s)
9
  14.8%
2
   3.1%
4
   3.4%
20.Secondary Outcome
Title Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Hide Description A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame During the entire study period (Day 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 31 31 60 30 34 58
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
1
   3.2%
1
   3.2%
1
   1.7%
1
   3.3%
0
   0.0%
3
   5.2%
Related SAE(s)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Hide Description Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.
Time Frame At Day 0, Day 21, Day 42 and Month 6 (M6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort including all vaccinated subjects with data available for the respective assays at the considered timepoints. Note that for Flu BS2 Groups, no blood samples were taken at Day 0 and Day 21 and hence no data for these timepoints are reported for the Flu BS2 Groups.
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description:
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination).
Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
Overall Number of Participants Analyzed 31 31 60 26 33 58
Measure Type: Count of Participants
Unit of Measure: Participants
ALAT, Day 0 Unknown Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
1
   3.2%
1
   1.7%
ALAT, Day 0 Below Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, Day 0 Within Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
29
  96.7%
30
  96.8%
58
  96.7%
ALAT, Day 0 Above Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
   1.7%
ALAT, Day 21 Unknown Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
0
   0.0%
1
   1.7%
ALAT, Day 21 Below Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, Day 21 Within Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
30
  96.8%
30
 100.0%
58
  98.3%
ALAT, Day 21 Above Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, Day 42 Unknown Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, Day 42 Below Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, Day 42 Within Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
31
 100.0%
30
 100.0%
55
  94.8%
26
 100.0%
32
  97.0%
56
  98.2%
ALAT, Day 42 Above Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
1
   3.0%
1
   1.8%
ALAT, M6 Unknown Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, M6 Below Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, M6 Within Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
30
 100.0%
29
 100.0%
56
  96.6%
24
 100.0%
29
 100.0%
52
  98.1%
ALAT, M6 Above Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
1
   1.9%
ASAT, Day 0 Unknown Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
1
   3.2%
1
   1.7%
ASAT, Day 0 Below Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
ASAT, Day 0 Within Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
26
  86.7%
29
  93.5%
58
  96.7%
ASAT, Day 0 Above Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
3
  10.0%
1
   3.2%
1
   1.7%
ASAT, Day 21 Unknown Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
0
   0.0%
1
   1.7%
ASAT, Day 21 Below Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
ASAT, Day 21 Within Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
30
  96.8%
29
  96.7%
58
  98.3%
ASAT, Day 21 Above Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
1
   3.3%
0
   0.0%
ASAT, Day 42 Unknown Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
1
   3.3%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT, Day 42 Below Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT, Day 42 Within Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
31
 100.0%
29
  96.7%
55
  94.8%
25
  96.2%
31
  93.9%
55
  96.5%
ASAT, Day 42 Above Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
1
   1.7%
1
   3.8%
2
   6.1%
2
   3.5%
ASAT, M6 Unknown Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT, M6 Below Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT, M6 Within Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
30
 100.0%
28
  96.6%
57
  98.3%
24
 100.0%
29
 100.0%
50
  94.3%
ASAT, M6 Above Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
1
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
3
   5.7%
Total Bilirubin, Day 0 Unknown Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
1
   3.2%
1
   1.7%
Total Bilirubin, Day 0 Below Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, Day 0 Within Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
29
  96.7%
28
  90.3%
57
  95.0%
Total Bilirubin, Day 0 Above Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
2
   6.5%
2
   3.3%
Total Bilirubin, Day 21 Unknown Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
0
   0.0%
1
   1.7%
Total Bilirubin, Day 21 Below Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, Day 21 Within Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
30
  96.8%
28
  93.3%
55
  93.2%
Total Bilirubin, Day 21 Above Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
2
   6.7%
3
   5.1%
Total Bilirubin, Day 42 Unknown Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, Day 42 Below Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, Day 42 Within Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
31
 100.0%
30
 100.0%
55
  94.8%
26
 100.0%
33
 100.0%
55
  96.5%
Total Bilirubin, Day 42 Above Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
2
   3.5%
Total Bilirubin, M6 Unknown Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, M6 Below Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, M6 Within Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
30
 100.0%
28
  96.6%
55
  94.8%
24
 100.0%
29
 100.0%
51
  96.2%
Total Bilirubin, M6 Above Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
1
   3.4%
2
   3.4%
0
   0.0%
0
   0.0%
2
   3.8%
Bilirubin Conjugated / Direct, Day 0 Unknown Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
1
   3.2%
1
   1.7%
Bilirubin Conjugated / Direct, Day 0 Below Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, Day 0 Within Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
29
  96.7%
30
  96.8%
58
  96.7%
Bilirubin Conjugated / Direct, Day 0 Above Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
1
   1.7%
Bilirubin Conjugated / Direct, Day 21 Unknown Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
0
   0.0%
1
   1.7%
Bilirubin Conjugated / Direct, Day 21 Below Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, Day 21 Within Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
30
  96.8%
30
 100.0%
58
  98.3%
Bilirubin Conjugated / Direct, Day 21 Above Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, Day 42 Unknown Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, Day 42 Below Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, Day 42 Within Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
31
 100.0%
30
 100.0%
56
  96.6%
26
 100.0%
33
 100.0%
57
 100.0%
Bilirubin Conjugated / Direct, Day 42 Above Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, M6 Unknown Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, M6 Below Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin Conjugated / Direct, M6 Within Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
30
 100.0%
29
 100.0%
57
  98.3%
24
 100.0%
29
 100.0%
53
 100.0%
Bilirubin Conjugated / Direct, M6 Above Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatine, Day 0 Unknown Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
1
   3.2%
1
   1.7%
Creatine, Day 0 Below Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
2
   6.7%
0
   0.0%
1
   1.7%
Creatine, Day 0 Within Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
27
  90.0%
29
  93.5%
52
  86.7%
Creatine, Day 0 Above Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
1
   3.2%
6
  10.0%
Creatine, Day 21 Unknown Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
0
   0.0%
1
   1.7%
Creatine, Day 21 Below Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
3
   9.7%
0
   0.0%
4
   6.8%
Creatine, Day 21 Within Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
27
  87.1%
28
  93.3%
48
  81.4%
Creatine, Day 21 Above Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
2
   6.7%
6
  10.2%
Creatine, Day 42 Unknown Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
Creatine, Day 42 Below Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
2
   6.5%
1
   3.3%
3
   5.2%
0
   0.0%
1
   3.0%
2
   3.5%
Creatine, Day 42 Within Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
28
  90.3%
29
  96.7%
52
  89.7%
24
  92.3%
31
  93.9%
51
  89.5%
Creatine, Day 42 Above Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
1
   3.2%
0
   0.0%
1
   1.7%
2
   7.7%
1
   3.0%
4
   7.0%
Creatine, M6 Unknown Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Creatine, M6 Below Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
1
   3.3%
1
   3.4%
2
   3.4%
1
   4.2%
0
   0.0%
5
   9.4%
Creatine, M6 Within Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
28
  93.3%
28
  96.6%
55
  94.8%
22
  91.7%
29
 100.0%
47
  88.7%
Creatine, M6 Above Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
1
   3.3%
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
1
   1.9%
BUN, Day 0 Unknown Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
1
   3.2%
1
   1.7%
BUN, Day 0 Below Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
2
   3.3%
BUN, Day 0 Within Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
28
  93.3%
30
  96.8%
57
  95.0%
BUN, Day 0 Above Number Analyzed 30 participants 31 participants 60 participants 0 participants 0 participants 0 participants
1
   3.3%
0
   0.0%
0
   0.0%
BUN, Day 21 Unknown Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
0
   0.0%
1
   1.7%
BUN, Day 21 Below Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
1
   3.2%
2
   6.7%
3
   5.1%
BUN, Day 21 Within Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
29
  93.5%
27
  90.0%
55
  93.2%
BUN, Day 21 Above Number Analyzed 31 participants 30 participants 59 participants 0 participants 0 participants 0 participants
0
   0.0%
1
   3.3%
0
   0.0%
BUN, Day 42 Unknown Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
BUN, Day 42 Below Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
1
   3.2%
2
   6.7%
1
   1.7%
1
   3.8%
0
   0.0%
0
   0.0%
BUN, Day 42 Within Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
29
  93.5%
28
  93.3%
55
  94.8%
23
  88.5%
32
  97.0%
56
  98.2%
BUN, Day 42 Above Number Analyzed 31 participants 30 participants 58 participants 26 participants 33 participants 57 participants
1
   3.2%
0
   0.0%
0
   0.0%
2
   7.7%
1
   3.0%
1
   1.8%
BUN, M6 Unknown Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
1
   3.3%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
BUN, M6 Below Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
1
   3.3%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
BUN, M6 Within Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
27
  90.0%
28
  96.6%
54
  93.1%
24
 100.0%
27
  93.1%
53
 100.0%
BUN, M6 Above Number Analyzed 30 participants 29 participants 58 participants 24 participants 29 participants 53 participants
1
   3.3%
1
   3.4%
1
   1.7%
0
   0.0%
2
   6.9%
0
   0.0%
Time Frame SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Hide Arm/Group Description Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination).
All-Cause Mortality
Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/31 (3.23%)      1/31 (3.23%)      1/60 (1.67%)      1/30 (3.33%)      0/34 (0.00%)      3/58 (5.17%)    
Gastrointestinal disorders             
Ranula   0/31 (0.00%)  0 0/31 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 1/58 (1.72%)  1
Infections and infestations             
Febrile infection   0/31 (0.00%)  0 0/31 (0.00%)  0 0/60 (0.00%)  0 1/30 (3.33%)  1 0/34 (0.00%)  0 0/58 (0.00%)  0
Urinary tract infection   1/31 (3.23%)  1 0/31 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 0/58 (0.00%)  0
Injury, poisoning and procedural complications             
Facial bones fracture   0/31 (0.00%)  0 0/31 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 1/58 (1.72%)  1
Forearm fracture   0/31 (0.00%)  0 1/31 (3.23%)  1 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 0/58 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Ectopic pregnancy   0/31 (0.00%)  0 0/31 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 1/58 (1.72%)  1
Respiratory, thoracic and mediastinal disorders             
Asthma *  0/31 (0.00%)  0 0/31 (0.00%)  0 1/60 (1.67%)  1 0/30 (0.00%)  0 0/34 (0.00%)  0 0/58 (0.00%)  0
Vascular disorders             
Haematoma   0/31 (0.00%)  0 0/31 (0.00%)  0 0/60 (0.00%)  0 1/30 (3.33%)  1 0/34 (0.00%)  0 0/58 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flu BS1_3-5 Years Group Flu BS1_6-9 Years Group Flu BS1_10-17 Years Group Flu BS2_3-5 Years Group Flu BS2_6-9 Years Group Flu BS2_10-17 Years Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/31 (96.77%)      25/31 (80.65%)      56/60 (93.33%)      26/30 (86.67%)      26/34 (76.47%)      50/58 (86.21%)    
Eye disorders             
Conjunctivitis   3/31 (9.68%)  3 1/31 (3.23%)  1 0/60 (0.00%)  0 1/30 (3.33%)  1 0/34 (0.00%)  0 1/58 (1.72%)  1
Gastrointestinal disorders             
Diarrhoea   6/31 (19.35%)  7 0/31 (0.00%)  0 0/60 (0.00%)  0 4/30 (13.33%)  5 0/34 (0.00%)  0 0/58 (0.00%)  0
Gastrointestinal disorder   0/31 (0.00%)  0 7/31 (22.58%)  11 18/60 (30.00%)  21 0/30 (0.00%)  0 6/34 (17.65%)  7 12/58 (20.69%)  13
General disorders             
Chills   7/31 (22.58%)  11 7/31 (22.58%)  8 18/60 (30.00%)  24 3/30 (10.00%)  4 3/34 (8.82%)  4 17/58 (29.31%)  22
Fatigue   0/31 (0.00%)  0 13/31 (41.94%)  18 29/60 (48.33%)  37 0/30 (0.00%)  0 11/34 (32.35%)  15 24/58 (41.38%)  36
Influenza like illness   1/31 (3.23%)  1 1/31 (3.23%)  1 2/60 (3.33%)  2 1/30 (3.33%)  1 0/34 (0.00%)  0 4/58 (6.90%)  4
Pain   19/31 (61.29%)  29 24/31 (77.42%)  40 51/60 (85.00%)  92 21/30 (70.00%)  38 25/34 (73.53%)  42 45/58 (77.59%)  75
Pyrexia   15/31 (48.39%)  22 7/31 (22.58%)  10 19/60 (31.67%)  22 15/30 (50.00%)  22 9/34 (26.47%)  11 12/58 (20.69%)  14
Swelling   13/31 (41.94%)  16 13/31 (41.94%)  18 21/60 (35.00%)  28 9/30 (30.00%)  13 9/34 (26.47%)  13 25/58 (43.10%)  38
Infections and infestations             
Bronchitis   2/31 (6.45%)  2 0/31 (0.00%)  0 2/60 (3.33%)  2 4/30 (13.33%)  5 0/34 (0.00%)  0 1/58 (1.72%)  1
Gastroenteritis   2/31 (6.45%)  2 0/31 (0.00%)  0 0/60 (0.00%)  0 2/30 (6.67%)  2 0/34 (0.00%)  0 1/58 (1.72%)  1
Lice infestation   1/31 (3.23%)  1 1/31 (3.23%)  1 0/60 (0.00%)  0 2/30 (6.67%)  2 1/34 (2.94%)  1 1/58 (1.72%)  1
Nasopharyngitis   2/31 (6.45%)  3 0/31 (0.00%)  0 3/60 (5.00%)  4 4/30 (13.33%)  6 2/34 (5.88%)  2 4/58 (6.90%)  5
Otitis externa   2/31 (6.45%)  2 0/31 (0.00%)  0 1/60 (1.67%)  1 0/30 (0.00%)  0 0/34 (0.00%)  0 1/58 (1.72%)  1
Otitis media   0/31 (0.00%)  0 0/31 (0.00%)  0 1/60 (1.67%)  1 2/30 (6.67%)  2 0/34 (0.00%)  0 0/58 (0.00%)  0
Rhinitis   3/31 (9.68%)  3 1/31 (3.23%)  1 2/60 (3.33%)  2 2/30 (6.67%)  2 1/34 (2.94%)  1 1/58 (1.72%)  1
Upper respiratory tract infection   4/31 (12.90%)  4 1/31 (3.23%)  2 5/60 (8.33%)  5 4/30 (13.33%)  5 0/34 (0.00%)  0 2/58 (3.45%)  3
Viral infection   2/31 (6.45%)  2 2/31 (6.45%)  2 1/60 (1.67%)  1 1/30 (3.33%)  1 0/34 (0.00%)  0 3/58 (5.17%)  3
Metabolism and nutrition disorders             
Decreased appetite   10/31 (32.26%)  12 0/31 (0.00%)  0 1/60 (1.67%)  1 9/30 (30.00%)  13 0/34 (0.00%)  0 0/58 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia   0/31 (0.00%)  0 7/31 (22.58%)  10 11/60 (18.33%)  14 2/30 (6.67%)  2 7/34 (20.59%)  9 14/58 (24.14%)  17
Myalgia   0/31 (0.00%)  0 6/31 (19.35%)  10 21/60 (35.00%)  26 1/30 (3.33%)  1 7/34 (20.59%)  12 24/58 (41.38%)  29
Pain in extremity   0/31 (0.00%)  0 2/31 (6.45%)  2 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 0/58 (0.00%)  0
Nervous system disorders             
Headache   1/31 (3.23%)  1 9/31 (29.03%)  14 30/60 (50.00%)  47 4/30 (13.33%)  4 10/34 (29.41%)  13 31/58 (53.45%)  50
Somnolence   11/31 (35.48%)  16 0/31 (0.00%)  0 0/60 (0.00%)  0 9/30 (30.00%)  11 0/34 (0.00%)  0 0/58 (0.00%)  0
Psychiatric disorders             
Irritability   9/31 (29.03%)  13 0/31 (0.00%)  0 0/60 (0.00%)  0 9/30 (30.00%)  14 0/34 (0.00%)  0 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough   5/31 (16.13%)  7 1/31 (3.23%)  1 0/60 (0.00%)  0 5/30 (16.67%)  10 2/34 (5.88%)  3 2/58 (3.45%)  3
Skin and subcutaneous tissue disorders             
Eczema   2/31 (6.45%)  2 0/31 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0 0/34 (0.00%)  0 0/58 (0.00%)  0
Erythema   14/31 (45.16%)  18 16/31 (51.61%)  20 23/60 (38.33%)  34 14/30 (46.67%)  21 12/34 (35.29%)  16 23/58 (39.66%)  30
Hyperhidrosis   4/31 (12.90%)  4 4/31 (12.90%)  4 9/60 (15.00%)  10 5/30 (16.67%)  6 6/34 (17.65%)  6 9/58 (15.52%)  10
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00972517    
Other Study ID Numbers: 113638
2009-015011-41 ( EudraCT Number )
First Submitted: September 3, 2009
First Posted: September 7, 2009
Results First Submitted: November 8, 2016
Results First Posted: September 10, 2018
Last Update Posted: June 26, 2019