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Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years

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ClinicalTrials.gov Identifier: NCT00771615
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : September 4, 2014
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: GSK A/turkey H5N1 Influenza vaccine
Enrollment 469
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 49 72 41 60 40 61 46 59 41
Completed 48 [1] 70 [1] 40 [1] 59 [1] 40 [1] 60 [1] 45 [1] 58 [1] 41 [1]
Not Completed 1 2 1 1 0 1 1 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0             0             1             0
Lost to Follow-up             1             1             1             1             0             1             1             0             0
[1]
Up to Day 364
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group Total
Hide Arm/Group Description Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 49 72 41 60 40 61 46 59 41 469
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 72 participants 41 participants 60 participants 40 participants 61 participants 46 participants 59 participants 41 participants 469 participants
42.3  (11.47) 40.6  (12.02) 41.1  (11.82) 41.2  (12.33) 41.1  (12.46) 42.4  (11.15) 41.2  (9.78) 40.6  (12.01) 41.6  (11.60) 41.3  (11.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 72 participants 41 participants 60 participants 40 participants 61 participants 46 participants 59 participants 41 participants 469 participants
Female
29
  59.2%
42
  58.3%
20
  48.8%
38
  63.3%
21
  52.5%
40
  65.6%
31
  67.4%
37
  62.7%
19
  46.3%
277
  59.1%
Male
20
  40.8%
30
  41.7%
21
  51.2%
22
  36.7%
19
  47.5%
21
  34.4%
15
  32.6%
22
  37.3%
22
  53.7%
192
  40.9%
1.Primary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Time Frame At Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 126 113 84 80 127 112 79 85
Measure Type: Count of Participants
Unit of Measure: Participants
43
  91.5%
121
  96.0%
109
  96.5%
57
  67.9%
56
  70.0%
122
  96.1%
108
  96.4%
51
  64.6%
62
  72.9%
2.Primary Outcome
Title Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Hide Description A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Time Frame At Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 126 113 84 80 127 112 79 85
Measure Type: Count of Participants
Unit of Measure: Participants
44
  93.6%
125
  99.2%
113
 100.0%
76
  90.5%
67
  83.8%
127
 100.0%
111
  99.1%
69
  87.3%
74
  87.1%
3.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
Time Frame At Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 126 113 84 80 127 112 79 85
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
229.6
(148.6 to 354.9)
847.3
(686.1 to 1046.4)
810.5
(666.6 to 985.3)
121.9
(89.7 to 165.7)
86.9
(64.7 to 116.7)
838.5
(703.1 to 1000.1)
819.8
(647.8 to 1037.3)
97.9
(70.3 to 136.4)
108.6
(82.3 to 143.3)
4.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Time Frame At Day 0 to Day 42 and at Day 0 to Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Measure Type: Count of Participants
Unit of Measure: Participants
A/turkey, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
41
  87.2%
123
  96.1%
108
  95.6%
55
  64.7%
51
  63.7%
123
  95.3%
108
  96.4%
45
  57.0%
61
  70.9%
A/turkey, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
28
  59.6%
105
  82.0%
90
  79.6%
38
  45.2%
38
  48.1%
103
  79.8%
92
  82.1%
31
  39.2%
45
  53.6%
5.Secondary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Hide Description Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Time Frame At Day 0, Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/turkey, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
6.1
(5.0 to 7.5)
13.5
(11.3 to 16.3)
14.4
(11.6 to 18.0)
14.2
(11.3 to 17.9)
10.9
(8.7 to 13.6)
14.1
(11.6 to 17.2)
13.7
(11.1 to 16.9)
13.2
(10.3 to 17.1)
11.8
(9.6 to 14.5)
A/turkey, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
229.6
(148.6 to 354.9)
847.3
(686.1 to 1046.4)
810.5
(666.6 to 985.3)
121.9
(89.7 to 165.7)
86.9
(64.7 to 116.7)
838.5
(703.1 to 1000.1)
819.8
(647.8 to 1037.3)
97.9
(70.3 to 136.4)
108.6
(82.3 to 143.3)
A/turkey, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
155.4
(102.1 to 236.3)
652.2
(525.3 to 809.8)
699.5
(561.9 to 870.8)
126.3
(91.6 to 174.1)
81.4
(59.6 to 111.2)
653.9
(545.5 to 783.9)
697.8
(539.2 to 903.2)
90.9
(64.7 to 127.6)
113.6
(84.1 to 153.4)
A/turkey, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
40.9
(26.8 to 62.4)
221.5
(172.3 to 284.6)
238.4
(185.1 to 307.0)
62.7
(44.9 to 87.5)
42.9
(31.6 to 58.3)
213.3
(170.5 to 266.9)
249.1
(187.6 to 330.8)
51.1
(37.2 to 70.3)
53.2
(38.3 to 73.8)
6.Secondary Outcome
Title HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Hide Description GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Time Frame At Day 0 to Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold change
A/turkey, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
37.4
(23.3 to 59.9)
61.6
(47.4 to 80.1)
56.3
(43.5 to 72.8)
8.5
(6.0 to 12.1)
8.0
(6.0 to 10.7)
58.4
(45.5 to 74.9)
59.8
(45.5 to 78.6)
7.4
(5.2 to 10.5)
9.1
(6.8 to 12.3)
A/turkey, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
25.3
(16.6 to 38.5)
48.2
(37.2 to 62.5)
48.6
(37.5 to 63.0)
8.9
(6.2 to 12.9)
7.5
(5.6 to 10.1)
46.3
(36.2 to 59.2)
50.9
(38.6 to 67.1)
6.9
(4.8 to 9.8)
9.6
(7.1 to 13.1)
A/turkey, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
6.7
(4.4 to 10.0)
16.4
(12.4 to 21.5)
16.6
(12.7 to 21.6)
4.4
(3.0 to 6.3)
3.9
(2.9 to 5.2)
15.1
(11.6 to 19.6)
18.2
(13.7 to 24.1)
3.9
(2.7 to 5.4)
4.4
(3.2 to 6.1)
7.Secondary Outcome
Title HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Hide Description Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Time Frame At Day 0, Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/Indo, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
7.3
(5.6 to 9.4)
26.1
(20.8 to 32.7)
23.8
(18.6 to 30.5)
25.5
(19.3 to 33.7)
18.5
(13.9 to 24.5)
25.5
(20.2 to 32.1)
24.5
(19.2 to 31.1)
22.0
(16.6 to 29.1)
21.7
(16.3 to 28.8)
A/Indo, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
286.5
(187.6 to 437.5)
905.0
(743.7 to 1101.4)
888.6
(739.6 to 1067.5)
176.7
(131.9 to 236.8)
113.6
(83.2 to 155.1)
873.5
(738.5 to 1033.3)
924.9
(745.0 to 1148.1)
124.6
(89.4 to 173.8)
161.3
(122.3 to 212.8)
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
192.3
(129.3 to 286.1)
740.8
(604.7 to 907.4)
798.1
(656.6 to 970.1)
168.7
(123.5 to 230.5)
108.8
(77.7 to 152.4)
728.1
(613.5 to 864.1)
814.6
(646.3 to 1026.8)
107.8
(75.6 to 153.8)
169.3
(126.1 to 227.2)
A/Indo, D182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
34.8
(22.6 to 53.6)
213.8
(166.4 to 274.6)
224.2
(174.4 to 288.3)
58.7
(41.2 to 83.6)
38.6
(28.0 to 53.3)
197.3
(156.0 to 249.5)
246.0
(188.0 to 321.9)
42.7
(30.4 to 60.0)
53.4
(37.9 to 75.2)
8.Secondary Outcome
Title Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
Hide Description A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Time Frame At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Measure Type: Count of Participants
Unit of Measure: Participants
A/Indo, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
5
  10.6%
70
  54.7%
56
  49.6%
44
  51.8%
31
  38.8%
68
  52.7%
58
  51.8%
34
  43.0%
41
  47.7%
A/Indo, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
44
  93.6%
125
  99.2%
113
 100.0%
79
  94.0%
68
  85.0%
127
 100.0%
111
  99.1%
69
  87.3%
78
  91.8%
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
44
  93.6%
126
  98.4%
113
 100.0%
78
  91.8%
67
  83.8%
129
 100.0%
110
  98.2%
66
  83.5%
79
  91.9%
A/Indo, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
28
  59.6%
116
  90.6%
106
  93.8%
58
  69.0%
47
  59.5%
121
  93.8%
101
  90.2%
48
  60.8%
57
  67.9%
A/turkey, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
3
   6.4%
32
  25.0%
35
  31.0%
25
  29.4%
16
  20.0%
36
  27.9%
31
  27.7%
23
  29.1%
18
  20.9%
A/turkey, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
41
  87.2%
126
  98.4%
113
 100.0%
74
  87.1%
62
  77.5%
129
 100.0%
110
  98.2%
64
  81.0%
72
  83.7%
A/turkey, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
31
  66.0%
119
  93.0%
106
  93.8%
58
  69.0%
53
  67.1%
122
  94.6%
103
  92.0%
54
  68.4%
57
  67.9%
9.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame At Day 0 to Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Measure Type: Count of Participants
Unit of Measure: Participants
A/Indo, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
42
  89.4%
122
  96.8%
108
  95.6%
50
  59.5%
44
  55.0%
122
  96.1%
108
  96.4%
41
  51.9%
53
  62.4%
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
42
  89.4%
120
  93.8%
105
  92.9%
48
  56.5%
43
  53.8%
121
  93.8%
104
  92.9%
38
  48.1%
53
  61.6%
A/Indo, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
25
  53.2%
91
  71.1%
84
  74.3%
24
  28.6%
22
  27.8%
96
  74.4%
79
  70.5%
20
  25.3%
26
  31.0%
10.Secondary Outcome
Title HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
Hide Description GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Time Frame At Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold change
A/Indo, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
39.3
(24.8 to 62.4)
34.7
(26.8 to 44.8)
37.3
(28.5 to 48.8)
6.8
(4.9 to 9.5)
6.1
(4.5 to 8.3)
34.3
(26.8 to 43.8)
37.8
(28.5 to 50.2)
5.7
(4.1 to 7.9)
7.3
(5.4 to 10.0)
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
26.4
(17.2 to 40.5)
28.4
(22.0 to 36.7)
33.5
(25.4 to 44.3)
6.6
(4.7 to 9.4)
5.9
(4.3 to 8.1)
28.6
(22.3 to 36.6)
33.3
(24.9 to 44.5)
4.9
(3.4 to 7.0)
7.8
(5.7 to 10.7)
A/Indo, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
4.8
(3.1 to 7.4)
8.2
(6.3 to 10.7)
9.4
(7.2 to 12.3)
2.3
(1.6 to 3.3)
2.1
(1.6 to 2.8)
7.7
(6.0 to 9.9)
10.1
(7.6 to 13.4)
1.9
(1.4 to 2.7)
2.5
(1.8 to 3.4)
11.Secondary Outcome
Title Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Hide Description MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.
Time Frame At Day 0, Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/turkey, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
27.5
(20.6 to 36.7)
115.4
(92.7 to 143.7)
114.6
(91.0 to 144.4)
102.9
(82.4 to 128.4)
94.9
(71.0 to 126.9)
115.0
(92.4 to 143.2)
115.1
(91.3 to 145.0)
95.9
(73.8 to 124.6)
101.9
(79.2 to 130.9)
A/turkey, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
2211.5
(1579.1 to 3097.1)
5367.7
(4604.3 to 6257.6)
5191.4
(4403.4 to 6120.5)
1276.2
(962.5 to 1692.1)
976.0
(740.6 to 1286.1)
5670.5
(4958.4 to 6484.8)
4876.8
(4057.3 to 5861.7)
1026.9
(756.6 to 1393.9)
1213.4
(939.3 to 1567.5)
A/turkey, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 79 participants 129 participants 112 participants 79 participants 85 participants
1582.9
(1080.4 to 2319.0)
4777.7
(4037.3 to 5654.0)
4649.4
(3884.9 to 5564.3)
1261.2
(950.0 to 1674.2)
906.0
(673.6 to 1218.6)
4915.6
(4212.6 to 5735.8)
4498.4
(3699.9 to 5469.2)
935.7
(688.9 to 1271.0)
1223.9
(929.0 to 1612.3)
A/turkey, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
349.7
(246.2 to 496.7)
1509.9
(1230.5 to 1852.8)
1484.8
(1181.6 to 1865.8)
471.5
(352.2 to 631.3)
342.2
(254.8 to 459.7)
1375.0
(1123.6 to 1682.7)
1653.6
(1313.4 to 2081.9)
332.3
(245.2 to 450.3)
484.8
(365.7 to 642.8)
A/Indo, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
72.8
(52.0 to 101.9)
326.0
(280.2 to 379.3)
300.2
(256.7 to 351.1)
343.4
(288.8 to 408.2)
262.0
(220.9 to 310.9)
308.1
(263.0 to 361.0)
320.1
(276.3 to 371.0)
288.1
(238.3 to 348.3)
313.7
(267.3 to 368.2)
A/Indo, D 10 Number Analyzed 47 participants 126 participants 113 participants 85 participants 80 participants 127 participants 112 participants 79 participants 85 participants
2311.5
(1708.9 to 3126.5)
5807.1
(5144.8 to 6554.7)
5680.0
(4943.7 to 6525.9)
1516.5
(1194.5 to 1925.3)
1250.0
(1002.6 to 1558.5)
6011.0
(5424.1 to 6661.5)
5460.9
(4670.2 to 6385.4)
1240.9
(966.2 to 1593.7)
1523.4
(1233.4 to 1881.5)
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
1622.0
(1105.2 to 2380.4)
5080.1
(4412.0 to 5849.3)
5054.1
(4276.6 to 5972.8)
1537.2
(1192.0 to 1982.3)
1194.5
(940.0 to 1517.9)
5157.1
(4518.4 to 5886.0)
4967.0
(4163.2 to 5926.0)
1178.0
(916.6 to 1514.0)
1552.4
(1216.5 to 1981.0)
A/Indo, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
380.8
(267.5 to 542.1)
1482.3
(1223.3 to 1796.1)
1556.0
(1265.4 to 1913.3)
535.5
(416.8 to 688.0)
378.4
(288.7 to 496.1)
1358.2
(1130.0 to 1632.5)
1721.5
(1390.0 to 2132.1)
379.4
(287.9 to 500.0)
534.2
(417.9 to 682.8)
A/Vie, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
181.3
(138.5 to 237.4)
210.1
(177.0 to 249.4)
249.0
(217.8 to 284.7)
197.3
(159.0 to 244.9)
205.5
(161.8 to 261.1)
237.5
(206.4 to 273.2)
216.5
(181.6 to 258.2)
198.7
(155.2 to 254.3)
203.7
(165.2 to 251.0)
A/Vie, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
662.5
(526.4 to 833.9)
1564.1
(1312.0 to 1864.7)
1350.1
(1142.2 to 1595.8)
552.0
(447.8 to 680.4)
430.5
(351.8 to 527.0)
1485.0
(1250.8 to 1763.1)
1430.0
(1202.3 to 1700.8)
509.3
(408.1 to 635.6)
470.8
(387.7 to 571.8)
A/Vie, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
529.3
(426.2 to 657.2)
1213.8
(1004.5 to 1466.6)
1249.3
(1033.4 to 1510.3)
589.4
(469.5 to 739.9)
377.8
(311.3 to 458.5)
1168.1
(969.8 to 1407.1)
1306.0
(1076.8 to 1584.1)
481.8
(382.4 to 607.0)
469.0
(381.8 to 576.2)
A/Vie, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
112.5
(84.5 to 149.8)
432.5
(366.6 to 510.2)
324.9
(260.0 to 406.1)
172.7
(137.9 to 216.3)
144.1
(119.9 to 173.3)
371.4
(309.2 to 446.1)
386.3
(313.8 to 475.5)
151.7
(120.5 to 191.0)
164.5
(136.7 to 198.1)
12.Secondary Outcome
Title Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Hide Description A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
Time Frame At Day 0, Day 10, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Measure Type: Count of Participants
Unit of Measure: Participants
A/turkey, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
20
  42.6%
116
  90.6%
102
  90.3%
80
  94.1%
68
  85.0%
114
  88.4%
104
  92.9%
71
  89.9%
77
  89.5%
A/turkey, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
47
 100.0%
126
 100.0%
113
 100.0%
84
 100.0%
80
 100.0%
127
 100.0%
112
 100.0%
79
 100.0%
85
 100.0%
A/turkey, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 79 participants 129 participants 112 participants 79 participants 85 participants
47
 100.0%
128
 100.0%
113
 100.0%
85
 100.0%
79
 100.0%
129
 100.0%
112
 100.0%
79
 100.0%
85
 100.0%
A/turkey, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
46
  97.9%
128
 100.0%
111
  98.2%
82
  97.6%
77
  97.5%
127
  98.4%
112
 100.0%
75
  94.9%
84
 100.0%
A/Indo, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
36
  76.6%
126
  98.4%
112
  99.1%
85
 100.0%
79
  98.8%
127
  98.4%
111
  99.1%
78
  98.7%
86
 100.0%
A/Indo, D 10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
47
 100.0%
126
 100.0%
113
 100.0%
84
 100.0%
80
 100.0%
127
 100.0%
112
 100.0%
79
 100.0%
85
 100.0%
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
46
  97.9%
128
 100.0%
113
 100.0%
85
 100.0%
80
 100.0%
129
 100.0%
112
 100.0%
79
 100.0%
86
 100.0%
A/Indo, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
46
  97.9%
128
 100.0%
112
  99.1%
83
  98.8%
78
  98.7%
128
  99.2%
112
 100.0%
78
  98.7%
83
  98.8%
A/Vie, D 0 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
46
  97.9%
120
  93.8%
112
  99.1%
80
  94.1%
76
  95.0%
126
  97.7%
106
  94.6%
73
  92.4%
83
  96.5%
A/Vie, D10 Number Analyzed 47 participants 126 participants 113 participants 84 participants 80 participants 127 participants 112 participants 79 participants 85 participants
47
 100.0%
126
 100.0%
113
 100.0%
84
 100.0%
80
 100.0%
127
 100.0%
112
 100.0%
79
 100.0%
85
 100.0%
A/Vie, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
47
 100.0%
128
 100.0%
112
  99.1%
85
 100.0%
80
 100.0%
128
  99.2%
112
 100.0%
79
 100.0%
86
 100.0%
A/Vie, D 182 Number Analyzed 47 participants 128 participants 113 participants 84 participants 79 participants 129 participants 112 participants 79 participants 84 participants
44
  93.6%
126
  98.4%
106
  93.8%
80
  95.2%
77
  97.5%
124
  96.1%
108
  96.4%
74
  93.7%
83
  98.8%
13.Secondary Outcome
Title Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Hide Description VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
Time Frame At Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 126 113 84 80 127 112 79 85
Measure Type: Count of Participants
Unit of Measure: Participants
A/turkey, Day 10
46
  97.9%
122
  96.8%
112
  99.1%
66
  78.6%
56
  70.0%
124
  97.6%
110
  98.2%
55
  69.6%
67
  78.8%
A/Indo, Day 10
45
  95.7%
121
  96.0%
105
  92.9%
36
  42.9%
40
  50.0%
122
  96.1%
104
  92.9%
32
  40.5%
44
  51.8%
A/Vie, Day 10
19
  40.4%
84
  66.7%
64
  56.6%
29
  34.5%
18
  22.5%
75
  59.1%
73
  65.2%
24
  30.4%
23
  27.1%
14.Secondary Outcome
Title Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
Hide Description VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 85 80 129 112 79 86
Measure Type: Count of Participants
Unit of Measure: Participants
A/turkey, Day 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 79 participants 129 participants 112 participants 79 participants 85 participants
46
  97.9%
121
  94.5%
110
  97.3%
67
  78.8%
58
  73.4%
122
  94.6%
109
  97.3%
56
  70.9%
69
  81.2%
A/Indo, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
41
  87.2%
118
  92.2%
103
  91.2%
39
  45.9%
38
  47.5%
119
  92.2%
102
  91.1%
31
  39.2%
46
  53.5%
A/Vie, D 42 Number Analyzed 47 participants 128 participants 113 participants 85 participants 80 participants 129 participants 112 participants 79 participants 86 participants
15
  31.9%
73
  57.0%
65
  57.5%
32
  37.6%
15
  18.8%
71
  55.0%
67
  59.8%
25
  31.6%
22
  25.6%
15.Secondary Outcome
Title Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Hide Description VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
Time Frame At Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
Arm/Group Title A/Turkey H5N1 Influenza A Group A/Turkey H5N1 Influenza B1 + D1 Group A/Turkey H5N1 Influenza C1 + E1 Group A/Turkey H5N1 Influenza B2 + D2 Group A/Turkey H5N1 Influenza C2 + E2 Group A/Turkey H5N1 Influenza B1 + C1 Group A/Turkey H5N1 Influenza D1 + E1 Group A/Turkey H5N1 Influenza B2 + C2 Group A/Turkey H5N1 Influenza D2 + E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.

The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 47 128 113 84 79 129 112 79 84
Measure Type: Count of Participants
Unit of Measure: Participants
A/turkey, Day 182
34
  72.3%
103
  80.5%
89
  78.8%
43
  51.2%
36
  45.6%
102
  79.1%
90
  80.4%
35
  44.3%
44
  52.4%
A/Indo, Day 182
28
  59.6%
68
  53.1%
72
  63.7%
15
  17.9%
17
  21.5%
71
  55.0%
69
  61.6%
13
  16.5%
19
  22.6%
A/Vie, Day 182
5
  10.6%
32
  25.0%
22
  19.5%
11
  13.1%
5
   6.3%
24
  18.6%
30
  26.8%
7
   8.9%
9
  10.7%
16.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.
Time Frame Within the 7-day (Days 0-6) post vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 49 72 40 60 40 60 46 58 41
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
41
  83.7%
59
  81.9%
9
  22.5%
53
  88.3%
10
  25.0%
48
  80.0%
13
  28.3%
46
  79.3%
6
  14.6%
Any Redness
1
   2.0%
3
   4.2%
0
   0.0%
4
   6.7%
0
   0.0%
4
   6.7%
0
   0.0%
1
   1.7%
0
   0.0%
Any Swelling
6
  12.2%
2
   2.8%
0
   0.0%
4
   6.7%
0
   0.0%
5
   8.3%
1
   2.2%
2
   3.4%
0
   0.0%
17.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Hide Description Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).
Time Frame Within the 7-day (Days 0-6) post vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 49 72 40 60 40 60 46 58 41
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
10
  20.4%
18
  25.0%
3
   7.5%
20
  33.3%
6
  15.0%
18
  30.0%
4
   8.7%
23
  39.7%
11
  26.8%
Any Headache
11
  22.4%
22
  30.6%
4
  10.0%
25
  41.7%
5
  12.5%
17
  28.3%
8
  17.4%
17
  29.3%
10
  24.4%
Any Joint pain
5
  10.2%
16
  22.2%
1
   2.5%
10
  16.7%
4
  10.0%
12
  20.0%
2
   4.3%
19
  32.8%
4
   9.8%
Any Muscle aches
10
  20.4%
29
  40.3%
3
   7.5%
17
  28.3%
7
  17.5%
21
  35.0%
8
  17.4%
28
  48.3%
8
  19.5%
Any Shivering
3
   6.1%
9
  12.5%
1
   2.5%
8
  13.3%
0
   0.0%
7
  11.7%
1
   2.2%
9
  15.5%
2
   4.9%
Any Sweating
4
   8.2%
4
   5.6%
0
   0.0%
5
   8.3%
0
   0.0%
3
   5.0%
1
   2.2%
6
  10.3%
2
   4.9%
Any Fever
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
4
   6.7%
0
   0.0%
4
   6.9%
0
   0.0%
18.Secondary Outcome
Title Number of Subjects With 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 such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Time Frame From Day 0 to Day 378
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 49 72 41 60 40 61 46 59 41
Measure Type: Count of Participants
Unit of Measure: Participants
17
  34.7%
24
  33.3%
13
  31.7%
18
  30.0%
13
  32.5%
21
  34.4%
16
  34.8%
20
  33.9%
10
  24.4%
19.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as an 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 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame From Day 0 to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 49 72 41 60 40 61 46 59 41
Measure Type: Count of Participants
Unit of Measure: Participants
9
  18.4%
27
  37.5%
12
  29.3%
26
  43.3%
11
  27.5%
21
  34.4%
12
  26.1%
23
  39.0%
9
  22.0%
20.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Hide Description A SAE was defined as 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.
Time Frame From Day 0 to Day 378
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description:
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 49 72 41 60 40 61 46 59 41
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
0
   0.0%
1
   2.4%
1
   1.7%
3
   7.5%
1
   1.6%
1
   2.2%
0
   0.0%
0
   0.0%
Time Frame Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 378; Systematically assessed adverse events (AEs): During the 7-day (Days 0-6) post vaccination period. Non-systematically assessed AE: During Days 0 - 42.
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
 
Arm/Group Title A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Hide Arm/Group Description Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
All-Cause Mortality
A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/49 (2.04%)   0/72 (0.00%)   1/41 (2.44%)   1/60 (1.67%)   3/40 (7.50%)   1/61 (1.64%)   1/46 (2.17%)   0/59 (0.00%)   0/41 (0.00%) 
Infections and infestations                   
Appendicitis * 1  0/49 (0.00%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  2/40 (5.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Pneumonia * 1  0/49 (0.00%)  0/72 (0.00%)  0/41 (0.00%)  1/60 (1.67%)  1/40 (2.50%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Lung cancer metastatic * 1  0/49 (0.00%)  0/72 (0.00%)  0/41 (0.00%)  1/60 (1.67%)  0/40 (0.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Thyroid cancer * 1  0/49 (0.00%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Nervous system disorders                   
Status epilepticus * 1  1/49 (2.04%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Psychiatric disorders                   
Drug abuse * 1  1/49 (2.04%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Renal and urinary disorders                   
Renal colic * 1  0/49 (0.00%)  0/72 (0.00%)  1/41 (2.44%)  0/60 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Acute respiratory failure * 1  1/49 (2.04%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders                   
Psoriasis * 1  0/49 (0.00%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/46 (2.17%)  0/59 (0.00%)  0/41 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A/Turkey H5N1 Influenza Formulation A Group A/Turkey H5N1 Influenza Formulation B1 Group A/Turkey H5N1 Influenza Formulation B2 Group A/Turkey H5N1 Influenza Formulation C1 Group A/Turkey H5N1 Influenza Formulation C2 Group A/Turkey H5N1 Influenza Formulation D1 Group A/Turkey H5N1 Influenza Formulation D2 Group A/Turkey H5N1 Influenza Formulation E1 Group A/Turkey H5N1 Influenza Formulation E2 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/49 (91.84%)   60/72 (83.33%)   15/41 (36.59%)   54/60 (90.00%)   19/40 (47.50%)   52/61 (85.25%)   21/46 (45.65%)   51/59 (86.44%)   21/41 (51.22%) 
Gastrointestinal disorders                   
Diarrhoea * 1  0/49 (0.00%)  1/72 (1.39%)  2/41 (4.88%)  3/60 (5.00%)  0/40 (0.00%)  1/61 (1.64%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
General disorders                   
Pain † 1  41/49 (83.67%)  59/72 (81.94%)  9/40 (22.50%)  53/60 (88.33%)  10/40 (25.00%)  48/60 (80.00%)  13/46 (28.26%)  46/58 (79.31%)  6/41 (14.63%) 
Redness † 1  1/49 (2.04%)  3/72 (4.17%)  0/40 (0.00%)  4/60 (6.67%)  0/40 (0.00%)  4/60 (6.67%)  0/46 (0.00%)  1/58 (1.72%)  0/41 (0.00%) 
Swelling † 1  6/49 (12.24%)  2/72 (2.78%)  0/40 (0.00%)  4/60 (6.67%)  0/40 (0.00%)  5/60 (8.33%)  1/46 (2.17%)  2/58 (3.45%)  0/41 (0.00%) 
Fatigue † 1  10/49 (20.41%)  18/72 (25.00%)  3/40 (7.50%)  20/60 (33.33%)  6/40 (15.00%)  18/60 (30.00%)  4/46 (8.70%)  23/58 (39.66%)  11/41 (26.83%) 
Headache † 1  11/49 (22.45%)  22/72 (30.56%)  4/40 (10.00%)  25/60 (41.67%)  5/40 (12.50%)  17/60 (28.33%)  8/46 (17.39%)  17/58 (29.31%)  10/41 (24.39%) 
Muscle aches † 1  10/49 (20.41%)  29/72 (40.28%)  3/40 (7.50%)  17/60 (28.33%)  7/40 (17.50%)  21/60 (35.00%)  8/46 (17.39%)  28/58 (48.28%)  8/41 (19.51%) 
Shivering † 1  3/49 (6.12%)  9/72 (12.50%)  1/40 (2.50%)  8/60 (13.33%)  0/40 (0.00%)  7/60 (11.67%)  1/46 (2.17%)  9/58 (15.52%)  2/41 (4.88%) 
Sweating † 1  4/49 (8.16%)  4/72 (5.56%)  0/40 (0.00%)  5/60 (8.33%)  0/40 (0.00%)  3/60 (5.00%)  1/46 (2.17%)  6/58 (10.34%)  2/41 (4.88%) 
Fever † 1  0/49 (0.00%)  1/72 (1.39%)  0/40 (0.00%)  0/60 (0.00%)  0/40 (0.00%)  4/60 (6.67%)  0/46 (0.00%)  4/58 (6.90%)  0/41 (0.00%) 
Infections and infestations                   
Joint pain † 1  5/49 (10.20%)  16/72 (22.22%)  1/40 (2.50%)  10/60 (16.67%)  4/40 (10.00%)  12/60 (20.00%)  2/46 (4.35%)  19/58 (32.76%)  4/41 (9.76%) 
Nasopharyngitis * 1  1/49 (2.04%)  3/72 (4.17%)  0/41 (0.00%)  5/60 (8.33%)  1/40 (2.50%)  2/61 (3.28%)  1/46 (2.17%)  3/59 (5.08%)  1/41 (2.44%) 
Upper respiratory tract infection * 1  0/49 (0.00%)  2/72 (2.78%)  1/41 (2.44%)  0/60 (0.00%)  1/40 (2.50%)  2/61 (3.28%)  3/46 (6.52%)  3/59 (5.08%)  1/41 (2.44%) 
Bronchitis * 1  0/49 (0.00%)  0/72 (0.00%)  1/41 (2.44%)  3/60 (5.00%)  0/40 (0.00%)  0/61 (0.00%)  1/46 (2.17%)  1/59 (1.69%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia * 1  2/49 (4.08%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  2/40 (5.00%)  0/61 (0.00%)  0/46 (0.00%)  1/59 (1.69%)  0/41 (0.00%) 
Musculoskeletal stiffness * 1  0/49 (0.00%)  0/72 (0.00%)  0/41 (0.00%)  0/60 (0.00%)  2/40 (5.00%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  0/41 (0.00%) 
Nervous system disorders                   
Headache * 1  3/49 (6.12%)  4/72 (5.56%)  0/41 (0.00%)  1/60 (1.67%)  1/40 (2.50%)  6/61 (9.84%)  1/46 (2.17%)  0/59 (0.00%)  2/41 (4.88%) 
Respiratory, thoracic and mediastinal disorders                   
Oropharyngeal pain * 1  0/49 (0.00%)  2/72 (2.78%)  1/41 (2.44%)  1/60 (1.67%)  1/40 (2.50%)  0/61 (0.00%)  0/46 (0.00%)  0/59 (0.00%)  4/41 (9.76%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00771615    
Other Study ID Numbers: 111729
First Submitted: October 10, 2008
First Posted: October 13, 2008
Results First Submitted: December 19, 2013
Results First Posted: September 4, 2014
Last Update Posted: September 21, 2018