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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

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ClinicalTrials.gov Identifier: NCT00964158
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Pandemic influenza vaccine GSK2340272A
Enrollment 210
Recruitment Details  
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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Period Title: Overall Study
Started 53 57 100
Completed 53 56 92
Not Completed 0 1 8
Reason Not Completed
Lost to Follow-up             0             1             2
Withdrawal by Subject             0             0             6
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group Total
Hide Arm/Group Description Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Total of all reporting groups
Overall Number of Baseline Participants 53 57 100 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 57 participants 100 participants 210 participants
3.5  (0.7) 7.5  (1.18) 13.3  (2.23) 9.25  (4.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 57 participants 100 participants 210 participants
Female
31
  58.5%
25
  43.9%
61
  61.0%
117
  55.7%
Male
22
  41.5%
32
  56.1%
39
  39.0%
93
  44.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 53 participants 57 participants 100 participants 210 participants
Asian - East Asian heritage
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.5%
White - Caucasian/European heritage
53
 100.0%
56
  98.2%
99
  99.0%
208
  99.0%
Unspecified
0
   0.0%
0
   0.0%
1
   1.0%
1
   0.5%
1.Primary Outcome
Title Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Hide Description The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time Frame At Day 0
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 198
Measure Type: Count of Participants
Unit of Measure: Participants
40
  20.2%
2.Primary Outcome
Title Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Hide Description The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 194
Measure Type: Count of Participants
Unit of Measure: Participants
194
 100.0%
3.Primary Outcome
Title Titers for Serum HI Antibodies
Hide Description Antibody titers were 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.
Time Frame At Day 0
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
7.4
(6.4 to 8.5)
4.Primary Outcome
Title Titers for Serum HI Antibodies
Hide Description Antibody titers were 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.
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
1538.5
(1419.0 to 1668.2)
5.Primary Outcome
Title Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Hide Description A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 194
Measure Type: Count of Participants
Unit of Measure: Participants
191
  98.5%
6.Primary Outcome
Title Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Hide Description Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 194
Measure Type: Count of Participants
Unit of Measure: Participants
194
 100.0%
7.Primary Outcome
Title Seroconversion Factor (SCF) for HI Antibody Titers
Hide Description Seroconversion factor 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.
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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
208.5
(179.0 to 242.9)
8.Secondary Outcome
Title Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Hide Description The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
Time Frame At Days 0, 21, 42 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 42 50 87
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, Day 0 Number Analyzed 42 participants 50 participants 87 participants
0
   0.0%
6
  12.0%
22
  25.3%
Flu A/CAL/7/09, Day 21 Number Analyzed 41 participants 50 participants 87 participants
41
 100.0%
50
 100.0%
87
 100.0%
Flu A/CAL/7/09, Day 42 Number Analyzed 41 participants 49 participants 83 participants
41
 100.0%
49
 100.0%
83
 100.0%
Flu A/CAL/7/09, Month 12 Number Analyzed 42 participants 50 participants 87 participants
42
 100.0%
50
 100.0%
87
 100.0%
9.Secondary Outcome
Title Titers for Serum HI Antibodies
Hide Description Antibody titers were 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.
Time Frame At Days 0, 21, 42 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 42 50 87
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/CAL/7/09, Day 0 Number Analyzed 42 participants 50 participants 87 participants
5.0
(5.0 to 5.0)
6.3
(5.2 to 7.7)
8.9
(6.9 to 11.3)
Flu A/CAL/7/09, Day 21 Number Analyzed 41 participants 50 participants 87 participants
168.3
(140.5 to 201.6)
284.4
(218.3 to 370.5)
547.9
(457.1 to 656.8)
Flu A/CAL/7/09, Day 42 Number Analyzed 41 participants 49 participants 83 participants
1581.1
(1365.7 to 1830.6)
964.6
(847.4 to 1098.0)
1008.9
(881.3 to 1155.0)
Flu A/CAL/7/09, Month 12 Number Analyzed 42 participants 50 participants 87 participants
123.9
(102.8 to 149.3)
106.3
(88.6 to 127.5)
251.0
(206.6 to 304.9)
10.Secondary Outcome
Title Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Hide Description A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
Time Frame At Days 21, 42 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 42 50 87
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, Day 21 Number Analyzed 41 participants 50 participants 87 participants
41
 100.0%
50
 100.0%
85
  97.7%
Flu A/CAL/7/09, Day 42 Number Analyzed 41 participants 49 participants 83 participants
41
 100.0%
49
 100.0%
80
  96.4%
Flu A/CAL/7/09, Month 12 Number Analyzed 42 participants 50 participants 87 participants
42
 100.0%
48
  96.0%
82
  94.3%
11.Secondary Outcome
Title Number of Seroprotected Subjects in Terms of HI Antibodies
Hide Description Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Time Frame At Days 0, 21, 42 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 42 50 87
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/CAL/7/09, Day 0 Number Analyzed 42 participants 50 participants 87 participants
0
   0.0%
3
   6.0%
12
  13.8%
Flu A/CAL/7/09, Day 21 Number Analyzed 41 participants 50 participants 87 participants
41
 100.0%
50
 100.0%
87
 100.0%
Flu A/CAL/7/09, Day 42 Number Analyzed 41 participants 49 participants 83 participants
41
 100.0%
49
 100.0%
83
 100.0%
Flu A/CAL/7/09, Month 12 Number Analyzed 42 participants 50 participants 87 participants
42
 100.0%
49
  98.0%
87
 100.0%
12.Secondary Outcome
Title Seroconversion Factor (SCF) for HI Antibody Titers
Hide Description Seroconversion factor 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.
Time Frame At Days 21, 42 and at Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 42 50 87
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
Flu A/CAL/7/09, Day 21 Number Analyzed 41 participants 50 participants 87 participants
33.7
(28.1 to 40.3)
44.9
(36.0 to 56.1)
61.8
(48.4 to 78.8)
Flu A/CAL/7/09, Day 42 Number Analyzed 41 participants 49 participants 83 participants
316.2
(273.1 to 366.1)
151.7
(123.4 to 186.5)
119.8
(92.3 to 155.4)
Flu A/CAL/7/09, Month 12 Number Analyzed 42 participants 50 participants 87 participants
24.8
(20.6 to 29.9)
16.8
(13.8 to 20.5)
28.3
(22.2 to 36.1)
13.Secondary Outcome
Title Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Hide Description The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
Time Frame At Days 0, 21 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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 32 37 30
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Neth/602/09, Day 0 Number Analyzed 32 participants 37 participants 30 participants
1
   3.1%
6
  16.2%
3
  10.0%
Flu A/Neth/602/09, Day 21 Number Analyzed 32 participants 37 participants 30 participants
31
  96.9%
37
 100.0%
30
 100.0%
Flu A/Neth/602/09, Day 42 Number Analyzed 29 participants 37 participants 29 participants
29
 100.0%
37
 100.0%
29
 100.0%
14.Secondary Outcome
Title Titers for Serum Neutralizing Antibodies
Hide Description Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
Time Frame At Days 0, 21 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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 32 37 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Neth/602/09, Day 0 Number Analyzed 32 participants 37 participants 30 participants
4.1
(3.9 to 4.4)
6.1
(4.2 to 8.8)
5.3
(3.6 to 7.9)
Flu A/Neth/602/09, Day 21 Number Analyzed 32 participants 37 participants 30 participants
60.2
(42.4 to 85.5)
149.0
(80.7 to 275.0)
113.0
(71.5 to 178.8)
Flu A/Neth/602/09, Day 42 Number Analyzed 29 participants 37 participants 29 participants
1277.4
(895.1 to 1822.9)
751.0
(491.0 to 1148.6)
553.4
(388.4 to 788.4)
15.Secondary Outcome
Title Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Hide Description The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 25 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
32
 100.0%
28
 100.0%
16.Secondary Outcome
Title Titers for Serum Neutralizing Antibodies
Hide Description Antibody titers were 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.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 25 32 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
269.1
(198.9 to 363.9)
168.4
(121.0 to 234.4)
118.1
(85.6 to 163.0)
17.Secondary Outcome
Title Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Hide Description A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
Time Frame At Days 21 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 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 32 37 30
Measure Type: Count of Participants
Unit of Measure: Participants
Flu A/Neth/602/09, Day 21 Number Analyzed 32 participants 37 participants 30 participants
26
  81.3%
32
  86.5%
26
  86.7%
Flu A/Neth/602/09, Day 42 Number Analyzed 29 participants 37 participants 29 participants
29
 100.0%
37
 100.0%
29
 100.0%
18.Secondary Outcome
Title Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Hide Description A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 24 31 28
Measure Type: Count of Participants
Unit of Measure: Participants
24
 100.0%
30
  96.8%
25
  89.3%
19.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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 98
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 53 participants 57 participants 98 participants
40
  75.5%
54
  94.7%
91
  92.9%
Grade 3 Pain, Dose 1 Number Analyzed 53 participants 57 participants 98 participants
2
   3.8%
3
   5.3%
8
   8.2%
Any Redness, Dose 1 Number Analyzed 53 participants 57 participants 98 participants
15
  28.3%
14
  24.6%
21
  21.4%
Grade 3 Redness, Dose 1 Number Analyzed 53 participants 57 participants 98 participants
0
   0.0%
2
   3.5%
6
   6.1%
Any Swelling, Dose 1 Number Analyzed 53 participants 57 participants 98 participants
18
  34.0%
16
  28.1%
41
  41.8%
Grade 3 Swelling, Dose 1 Number Analyzed 53 participants 57 participants 98 participants
1
   1.9%
3
   5.3%
6
   6.1%
Any Pain, Dose 2 Number Analyzed 52 participants 57 participants 93 participants
44
  84.6%
55
  96.5%
90
  96.8%
Grade 3 Pain, Dose 2 Number Analyzed 52 participants 57 participants 93 participants
5
   9.6%
8
  14.0%
12
  12.9%
Any Redness, Dose 2 Number Analyzed 52 participants 57 participants 93 participants
18
  34.6%
19
  33.3%
26
  28.0%
Grade 3 Redness, Dose 2 Number Analyzed 52 participants 57 participants 93 participants
4
   7.7%
2
   3.5%
2
   2.2%
Any Swelling, Dose 2 Number Analyzed 52 participants 57 participants 93 participants
16
  30.8%
26
  45.6%
50
  53.8%
Grade 3 Swelling, Dose 2 Number Analyzed 52 participants 57 participants 93 participants
2
   3.8%
1
   1.8%
2
   2.2%
Any Pain, Across doses Number Analyzed 53 participants 57 participants 98 participants
47
  88.7%
56
  98.2%
95
  96.9%
Grade 3 Pain, Across doses Number Analyzed 53 participants 57 participants 98 participants
7
  13.2%
8
  14.0%
16
  16.3%
Any Redness, Across doses Number Analyzed 53 participants 57 participants 98 participants
22
  41.5%
22
  38.6%
33
  33.7%
Grade 3 Redness, Across doses Number Analyzed 53 participants 57 participants 98 participants
4
   7.5%
4
   7.0%
6
   6.1%
Any Swelling, Across doses Number Analyzed 53 participants 57 participants 98 participants
25
  47.2%
30
  52.6%
60
  61.2%
Grade 3 Swelling, Across doses Number Analyzed 53 participants 57 participants 98 participants
3
   5.7%
4
   7.0%
6
   6.1%
20.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
Arm/Group Title GSK2340272A (3-5Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
Any Diarrhea, Dose 1 Number Analyzed 53 participants
2
   3.8%
Grade 3 Diarrhea, Dose 1 Number Analyzed 53 participants
0
   0.0%
Related Diarrhea, Dose 1 Number Analyzed 53 participants
1
   1.9%
Any Drowsiness, Dose 1 Number Analyzed 53 participants
11
  20.8%
Grade 3 Drowsiness, Dose 1 Number Analyzed 53 participants
0
   0.0%
Related Drowsiness, Dose 1 Number Analyzed 53 participants
8
  15.1%
Any Irritability, Dose 1 Number Analyzed 53 participants
14
  26.4%
Grade 3 Irritability, Dose 1 Number Analyzed 53 participants
0
   0.0%
Related Irritability, Dose 1 Number Analyzed 53 participants
10
  18.9%
Any Loss of appetite, Dose 1 Number Analyzed 53 participants
14
  26.4%
Grade 3 Loss of appetite, Dose 1 Number Analyzed 53 participants
0
   0.0%
Related Loss of appetite, Dose 1 Number Analyzed 53 participants
8
  15.1%
Any Shivering, Dose 1 Number Analyzed 53 participants
5
   9.4%
Grade 3 Shivering, Dose 1 Number Analyzed 53 participants
0
   0.0%
Related Shivering, Dose 1 Number Analyzed 53 participants
2
   3.8%
Any Sweating, Dose 1 Number Analyzed 53 participants
4
   7.5%
Grade 3 Sweating, Dose 1 Number Analyzed 53 participants
0
   0.0%
Related Sweating, Dose 1 Number Analyzed 53 participants
1
   1.9%
Any Temperature, Dose 1 Number Analyzed 53 participants
14
  26.4%
Grade 3 Temperature, Dose 1 Number Analyzed 53 participants
1
   1.9%
Related Temperature, Dose 1 Number Analyzed 53 participants
8
  15.1%
Any Diarrhea, Dose 2 Number Analyzed 52 participants
6
  11.5%
Grade 3 Diarrhea, Dose 2 Number Analyzed 52 participants
0
   0.0%
Related Diarrhea, Dose 2 Number Analyzed 52 participants
3
   5.8%
Any Drowsiness, Dose 2 Number Analyzed 52 participants
17
  32.7%
Grade 3 Drowsiness, Dose 2 Number Analyzed 52 participants
2
   3.8%
Related Drowsiness, Dose 2 Number Analyzed 52 participants
15
  28.8%
Any Irritability, Dose 2 Number Analyzed 52 participants
15
  28.8%
Grade 3 Irritability, Dose 2 Number Analyzed 52 participants
3
   5.8%
Related Irritability, Dose 2 Number Analyzed 52 participants
14
  26.9%
Any Loss of appetite, Dose 2 Number Analyzed 52 participants
21
  40.4%
Grade 3 Loss of appetite, Dose 2 Number Analyzed 52 participants
3
   5.8%
Related Loss of appetite, Dose 2 Number Analyzed 52 participants
17
  32.7%
Any Shivering, Dose 2 Number Analyzed 52 participants
6
  11.5%
Grade 3 Shivering, Dose 2 Number Analyzed 52 participants
1
   1.9%
Related Shivering, Dose 2 Number Analyzed 52 participants
5
   9.6%
Any Sweating, Dose 2 Number Analyzed 52 participants
6
  11.5%
Grade 3 Sweating, Dose 2 Number Analyzed 52 participants
0
   0.0%
Related Sweating, Dose 2 Number Analyzed 52 participants
4
   7.7%
Any Temperature, Dose 2 Number Analyzed 52 participants
26
  50.0%
Grade 3 Temperature, Dose 2 Number Analyzed 52 participants
2
   3.8%
Related Temperature, Dose 2 Number Analyzed 52 participants
23
  44.2%
Any Diarrhea, Across doses Number Analyzed 53 participants
8
  15.1%
Grade 3 Diarrhea, Across doses Number Analyzed 53 participants
0
   0.0%
Related Diarrhea, Across doses Number Analyzed 53 participants
4
   7.5%
Any Drowsiness, Across doses Number Analyzed 53 participants
22
  41.5%
Grade 3 Drowsiness, Across doses Number Analyzed 53 participants
2
   3.8%
Related Drowsiness, Across doses Number Analyzed 53 participants
19
  35.8%
Any Irritability, Across doses Number Analyzed 53 participants
21
  39.6%
Grade 3 Irritability, Across doses Number Analyzed 53 participants
3
   5.7%
Related Irritability, Across doses Number Analyzed 53 participants
19
  35.8%
Any Loss of appetite, Across doses Number Analyzed 53 participants
28
  52.8%
Grade 3 Loss of appetite, Across doses Number Analyzed 53 participants
3
   5.7%
Related Loss of appetite, Across doses Number Analyzed 53 participants
21
  39.6%
Any Shivering, Across doses Number Analyzed 53 participants
11
  20.8%
Grade 3 Shivering, Across doses Number Analyzed 53 participants
1
   1.9%
Related Shivering, Across doses Number Analyzed 53 participants
7
  13.2%
Any Sweating, Across doses Number Analyzed 53 participants
10
  18.9%
Grade 3 Sweating, Across doses Number Analyzed 53 participants
0
   0.0%
Related Sweating, Across doses Number Analyzed 53 participants
5
   9.4%
Any Temperature, Across doses Number Analyzed 53 participants
33
  62.3%
Grade 3 Temperature, Across doses Number Analyzed 53 participants
3
   5.7%
Related Temperature, Across doses Number Analyzed 53 participants
26
  49.1%
21.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
Arm/Group Title GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 57 98
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia, Dose 1 Number Analyzed 57 participants 98 participants
9
  15.8%
26
  26.5%
Grade 3 Arthralgia, Dose 1 Number Analyzed 57 participants 98 participants
0
   0.0%
1
   1.0%
Related Arthralgia, Dose 1 Number Analyzed 57 participants 98 participants
8
  14.0%
26
  26.5%
Any Fatigue, Dose 1 Number Analyzed 57 participants 98 participants
21
  36.8%
44
  44.9%
Grade 3 Fatigue, Dose 1 Number Analyzed 57 participants 98 participants
1
   1.8%
4
   4.1%
Related Fatigue, Dose 1 Number Analyzed 57 participants 98 participants
20
  35.1%
40
  40.8%
Any Gastrointestinal, Dose 1 Number Analyzed 57 participants 98 participants
13
  22.8%
12
  12.2%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 57 participants 98 participants
2
   3.5%
1
   1.0%
Related Gastrointestinal, Dose 1 Number Analyzed 57 participants 98 participants
9
  15.8%
6
   6.1%
Any Headache, Dose 1 Number Analyzed 57 participants 98 participants
25
  43.9%
48
  49.0%
Grade 3 Headache, Dose 1 Number Analyzed 57 participants 98 participants
2
   3.5%
3
   3.1%
Related Headache, Dose 1 Number Analyzed 57 participants 98 participants
24
  42.1%
41
  41.8%
Any Myalgia, Dose 1 Number Analyzed 57 participants 98 participants
15
  26.3%
35
  35.7%
Grade 3 Myalgia, Dose 1 Number Analyzed 57 participants 98 participants
2
   3.5%
2
   2.0%
Related Myalgia, Dose 1 Number Analyzed 57 participants 98 participants
13
  22.8%
34
  34.7%
Any Shivering, Dose 1 Number Analyzed 57 participants 98 participants
7
  12.3%
19
  19.4%
Grade 3 Shivering, Dose 1 Number Analyzed 57 participants 98 participants
0
   0.0%
0
   0.0%
Related Shivering, Dose 1 Number Analyzed 57 participants 98 participants
4
   7.0%
14
  14.3%
Any Sweating, Dose 1 Number Analyzed 57 participants 98 participants
2
   3.5%
8
   8.2%
Grade 3 Sweating, Dose 1 Number Analyzed 57 participants 98 participants
0
   0.0%
0
   0.0%
Related Sweating, Dose 1 Number Analyzed 57 participants 98 participants
1
   1.8%
5
   5.1%
Any Temperature, Dose 1 Number Analyzed 57 participants 98 participants
13
  22.8%
17
  17.3%
Grade 3 Temperature, Dose 1 Number Analyzed 57 participants 98 participants
0
   0.0%
0
   0.0%
Related Temperature, Dose 1 Number Analyzed 57 participants 98 participants
10
  17.5%
15
  15.3%
Any Arthralgia, Dose 2 Number Analyzed 57 participants 93 participants
13
  22.8%
34
  36.6%
Grade 3 Arthralgia, Dose 2 Number Analyzed 57 participants 93 participants
1
   1.8%
1
   1.1%
Related Arthralgia, Dose 2 Number Analyzed 57 participants 93 participants
13
  22.8%
32
  34.4%
Any Fatigue, Dose 2 Number Analyzed 57 participants 93 participants
29
  50.9%
50
  53.8%
Grade 3 Fatigue, Dose 2 Number Analyzed 57 participants 93 participants
3
   5.3%
5
   5.4%
Related Fatigue, Dose 2 Number Analyzed 57 participants 93 participants
28
  49.1%
48
  51.6%
Any Gastrointestinal, Dose 2 Number Analyzed 57 participants 93 participants
9
  15.8%
10
  10.8%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 57 participants 93 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 2 Number Analyzed 57 participants 93 participants
8
  14.0%
6
   6.5%
Any Headache, Dose 2 Number Analyzed 57 participants 93 participants
26
  45.6%
51
  54.8%
Grade 3 Headache, Dose 2 Number Analyzed 57 participants 93 participants
4
   7.0%
5
   5.4%
Related Headache, Dose 2 Number Analyzed 57 participants 93 participants
26
  45.6%
50
  53.8%
Any Myalgia, Dose 2 Number Analyzed 57 participants 93 participants
16
  28.1%
47
  50.5%
Grade 3 Myalgia, Dose 2 Number Analyzed 57 participants 93 participants
1
   1.8%
2
   2.2%
Related Myalgia, Dose 2 Number Analyzed 57 participants 93 participants
16
  28.1%
44
  47.3%
Any Shivering, Dose 2 Number Analyzed 57 participants 93 participants
14
  24.6%
27
  29.0%
Grade 3 Shivering, Dose 2 Number Analyzed 57 participants 93 participants
0
   0.0%
1
   1.1%
Related Shivering, Dose 2 Number Analyzed 57 participants 93 participants
13
  22.8%
25
  26.9%
Any Sweating, Dose 2 Number Analyzed 57 participants 93 participants
7
  12.3%
8
   8.6%
Grade 3 Sweating, Dose 2 Number Analyzed 57 participants 93 participants
0
   0.0%
0
   0.0%
Related Sweating, Dose 2 Number Analyzed 57 participants 93 participants
4
   7.0%
7
   7.5%
Any Temperature, Dose 2 Number Analyzed 57 participants 93 participants
20
  35.1%
23
  24.7%
Grade 3 Temperature, Dose 2 Number Analyzed 57 participants 93 participants
1
   1.8%
1
   1.1%
Related Temperature, Dose 2 Number Analyzed 57 participants 93 participants
19
  33.3%
16
  17.2%
Any Arthralgia, Across doses Number Analyzed 57 participants 98 participants
20
  35.1%
44
  44.9%
Grade 3 Arthralgia, Across doses Number Analyzed 57 participants 98 participants
1
   1.8%
2
   2.0%
Related Arthralgia, Across doses Number Analyzed 57 participants 98 participants
19
  33.3%
43
  43.9%
Any Fatigue, Across doses Number Analyzed 57 participants 98 participants
35
  61.4%
63
  64.3%
Grade 3 Fatigue, Across doses Number Analyzed 57 participants 98 participants
4
   7.0%
9
   9.2%
Related Fatigue, Across doses Number Analyzed 57 participants 98 participants
34
  59.6%
59
  60.2%
Any Gastrointestinal, Across doses Number Analyzed 57 participants 98 participants
17
  29.8%
16
  16.3%
Grade 3 Gastrointestinal, Across doses Number Analyzed 57 participants 98 participants
2
   3.5%
1
   1.0%
Related Gastrointestinal, Across doses Number Analyzed 57 participants 98 participants
14
  24.6%
10
  10.2%
Any Headache, Across doses Number Analyzed 57 participants 98 participants
34
  59.6%
70
  71.4%
Grade 3 Headache, Across doses Number Analyzed 57 participants 98 participants
5
   8.8%
6
   6.1%
Related Headache, Across doses Number Analyzed 57 participants 98 participants
34
  59.6%
64
  65.3%
Any Myalgia, Across doses Number Analyzed 57 participants 98 participants
23
  40.4%
56
  57.1%
Grade 3 Myalgia, Across doses Number Analyzed 57 participants 98 participants
2
   3.5%
4
   4.1%
Related Myalgia, Across doses Number Analyzed 57 participants 98 participants
21
  36.8%
53
  54.1%
Any Shivering, Across doses Number Analyzed 57 participants 98 participants
19
  33.3%
38
  38.8%
Grade 3 Shivering, Across doses Number Analyzed 57 participants 98 participants
0
   0.0%
1
   1.0%
Related Shivering, Across doses Number Analyzed 57 participants 98 participants
15
  26.3%
33
  33.7%
Any Sweating, Across doses Number Analyzed 57 participants 98 participants
9
  15.8%
14
  14.3%
Grade 3 Sweating, Across doses Number Analyzed 57 participants 98 participants
0
   0.0%
0
   0.0%
Related Sweating, Across doses Number Analyzed 57 participants 98 participants
5
   8.8%
11
  11.2%
Any Temperature, Across doses Number Analyzed 57 participants 98 participants
27
  47.4%
33
  33.7%
Grade 3 Temperature, Across doses Number Analyzed 57 participants 98 participants
1
   1.8%
1
   1.0%
Related Temperature, Across doses Number Analyzed 57 participants 98 participants
23
  40.4%
25
  25.5%
22.Secondary Outcome
Title Number of Subjects With Any 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.
Time Frame During the entire study period (from Day 0 up to Month 12)
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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 100
Measure Type: Count of Participants
Unit of Measure: Participants
36
  67.9%
21
  36.8%
33
  33.0%
23.Secondary Outcome
Title Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Hide Description An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time Frame During the entire study period (from Day 0 up to Month 12)
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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Subjects With Normal or Abnormal Biochemical Levels
Hide Description Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
Time Frame At Days 0, 21 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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 97
Measure Type: Count of Participants
Unit of Measure: Participants
ALAT, Day 0 Number Analyzed 30 participants 38 participants 59 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
30
 100.0%
38
 100.0%
59
 100.0%
Above
0
   0.0%
0
   0.0%
0
   0.0%
ALAT, Day 21 Number Analyzed 53 participants 57 participants 97 participants
Unknown
1
   1.9%
0
   0.0%
2
   2.1%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
52
  98.1%
57
 100.0%
94
  96.9%
Above
0
   0.0%
0
   0.0%
1
   1.0%
ALAT, Day 42 Number Analyzed 52 participants 56 participants 93 participants
Unknown
2
   3.8%
1
   1.8%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
50
  96.2%
55
  98.2%
91
  97.8%
Above
0
   0.0%
0
   0.0%
2
   2.2%
ASAT, Day 0 Number Analyzed 30 participants 38 participants 59 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
28
  93.3%
38
 100.0%
58
  98.3%
Above
2
   6.7%
0
   0.0%
1
   1.7%
ASAT, Day 21 Number Analyzed 53 participants 57 participants 97 participants
Unknown
2
   3.8%
1
   1.8%
2
   2.1%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
50
  94.3%
56
  98.2%
94
  96.9%
Above
1
   1.9%
0
   0.0%
1
   1.0%
ASAT, Day 42 Number Analyzed 52 participants 56 participants 93 participants
Unknown
2
   3.8%
1
   1.8%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
50
  96.2%
55
  98.2%
91
  97.8%
Above
0
   0.0%
0
   0.0%
2
   2.2%
BILI, Day 0 Number Analyzed 30 participants 38 participants 59 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
30
 100.0%
38
 100.0%
57
  96.6%
Above
0
   0.0%
0
   0.0%
2
   3.4%
BILI, Day 21 Number Analyzed 53 participants 57 participants 97 participants
Unknown
1
   1.9%
0
   0.0%
2
   2.1%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
52
  98.1%
57
 100.0%
90
  92.8%
Above
0
   0.0%
0
   0.0%
5
   5.2%
BILI, Day 42 Number Analyzed 52 participants 56 participants 93 participants
Unknown
2
   3.8%
1
   1.8%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
50
  96.2%
55
  98.2%
90
  96.8%
Above
0
   0.0%
0
   0.0%
3
   3.2%
CREA, Day 0 Number Analyzed 30 participants 38 participants 59 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
Below
1
   3.3%
0
   0.0%
1
   1.7%
Within
28
  93.3%
33
  86.8%
54
  91.5%
Above
1
   3.3%
5
  13.2%
4
   6.8%
CREA, Day 21 Number Analyzed 53 participants 57 participants 97 participants
Unknown
1
   1.9%
0
   0.0%
2
   2.1%
Below
7
  13.2%
2
   3.5%
1
   1.0%
Within
44
  83.0%
53
  93.0%
90
  92.8%
Above
1
   1.9%
2
   3.5%
4
   4.1%
CREA, Day 42 Number Analyzed 52 participants 56 participants 93 participants
Unknown
2
   3.8%
1
   1.8%
0
   0.0%
Below
5
   9.6%
2
   3.6%
2
   2.2%
Within
45
  86.5%
52
  92.9%
85
  91.4%
Above
0
   0.0%
1
   1.8%
6
   6.5%
BUN, Day 0 Number Analyzed 30 participants 38 participants 59 participants
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
28
  93.3%
37
  97.4%
57
  96.6%
Above
2
   6.7%
1
   2.6%
2
   3.4%
BUN, Day 21 Number Analyzed 53 participants 57 participants 97 participants
Unknown
1
   1.9%
0
   0.0%
2
   2.1%
Below
1
   1.9%
0
   0.0%
0
   0.0%
Within
49
  92.5%
52
  91.2%
92
  94.8%
Above
2
   3.8%
5
   8.8%
3
   3.1%
BUN, Day 42 Number Analyzed 52 participants 56 participants 93 participants
Unknown
2
   3.8%
1
   1.8%
0
   0.0%
Below
0
   0.0%
0
   0.0%
0
   0.0%
Within
47
  90.4%
47
  83.9%
89
  95.7%
Above
3
   5.8%
8
  14.3%
4
   4.3%
25.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 During the 21-day (Days 0-20) follow-up period after the first vaccination
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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 100
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
29
  54.7%
22
  38.6%
30
  30.0%
Grade 3 AE(s)
4
   7.5%
2
   3.5%
1
   1.0%
Related AE(s)
2
   3.8%
4
   7.0%
6
   6.0%
26.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 During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 100
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
37
  69.8%
26
  45.6%
41
  41.0%
Grade 3 AE(s)
8
  15.1%
4
   7.0%
7
   7.0%
Related AE(s)
2
   3.8%
4
   7.0%
6
   6.0%
27.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 up to Month 12)
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 GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description:
Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 53 57 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   1.0%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 21-day (Days 0-20) period after the first vaccination and 62-day (Days 0-61) period after the second vaccination; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 12).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Hide Arm/Group Description Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
All-Cause Mortality
GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)      0/57 (0.00%)      0/100 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/57 (0.00%)      1/100 (1.00%)    
Blood and lymphatic system disorders       
Bone marrow failure  1  0/53 (0.00%)  0 0/57 (0.00%)  0 1/100 (1.00%)  1
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK2340272A (3-5Y) Group GSK2340272A (6-9Y) Group GSK2340272A (10-17Y) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/53 (98.11%)      57/57 (100.00%)      95/100 (95.00%)    
Gastrointestinal disorders       
Diarrhoea  1  8/53 (15.09%)  9 0/57 (0.00%)  0 0/100 (0.00%)  0
Gastrointestinal disorder  1  0/53 (0.00%)  0 17/57 (29.82%)  22 16/100 (16.00%)  23
Vomiting  1  3/53 (5.66%)  3 1/57 (1.75%)  1 0/100 (0.00%)  0
General disorders       
Chills  1  11/53 (20.75%)  11 19/57 (33.33%)  21 38/100 (38.00%)  47
Fatigue  1  0/53 (0.00%)  0 35/57 (61.40%)  50 63/100 (63.00%)  95
Pain  1  47/53 (88.68%)  85 56/57 (98.25%)  109 95/100 (95.00%)  181
Pyrexia  1  34/53 (64.15%)  44 28/57 (49.12%)  34 34/100 (34.00%)  41
Swelling  1  25/53 (47.17%)  34 30/57 (52.63%)  42 60/100 (60.00%)  91
Infections and infestations       
Ear infection  1  4/53 (7.55%)  5 0/57 (0.00%)  0 0/100 (0.00%)  0
Gastroenteritis  1  4/53 (7.55%)  5 1/57 (1.75%)  1 3/100 (3.00%)  3
Laryngitis  1  6/53 (11.32%)  6 2/57 (3.51%)  2 1/100 (1.00%)  1
Otitis media  1  3/53 (5.66%)  3 0/57 (0.00%)  0 0/100 (0.00%)  0
Pharyngitis  1  5/53 (9.43%)  6 1/57 (1.75%)  1 1/100 (1.00%)  1
Tonsillitis  1  3/53 (5.66%)  3 1/57 (1.75%)  1 6/100 (6.00%)  7
Upper respiratory tract infection  1  11/53 (20.75%)  15 3/57 (5.26%)  3 14/100 (14.00%)  19
Metabolism and nutrition disorders       
Decreased appetite  1  28/53 (52.83%)  35 1/57 (1.75%)  1 0/100 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/53 (0.00%)  0 20/57 (35.09%)  23 44/100 (44.00%)  60
Myalgia  1  0/53 (0.00%)  0 23/57 (40.35%)  31 56/100 (56.00%)  82
Nervous system disorders       
Headache  1  3/53 (5.66%)  3 34/57 (59.65%)  51 71/100 (71.00%)  105
Somnolence  1  22/53 (41.51%)  28 0/57 (0.00%)  0 0/100 (0.00%)  0
Psychiatric disorders       
Irritability  1  21/53 (39.62%)  29 0/57 (0.00%)  0 0/100 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  5/53 (9.43%)  9 3/57 (5.26%)  3 4/100 (4.00%)  4
Nasal congestion  1  0/53 (0.00%)  0 3/57 (5.26%)  3 1/100 (1.00%)  1
Oropharyngeal pain  1  0/53 (0.00%)  0 3/57 (5.26%)  3 0/100 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema  1  22/53 (41.51%)  33 22/57 (38.60%)  33 33/100 (33.00%)  47
Hyperhidrosis  1  10/53 (18.87%)  10 9/57 (15.79%)  9 14/100 (14.00%)  16
1
Term from vocabulary, MedDRA 13.1
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
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00964158     History of Changes
Other Study ID Numbers: 113528
First Submitted: August 20, 2009
First Posted: August 24, 2009
Results First Submitted: July 31, 2017
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018